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bupropion hydrochloride 150 mg Tablet, Film Coated, Extended Release, 33,225-count — NDC 00591-3543-88 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

bupropion hydrochloride 150 mg Tablet, Film Coated, Extended Release, 33,225-count — NDC 0591-3543-88 (Billing 00591-3543-88)

by Actavis Pharma, Inc. · 33225 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM

This is a package of 33,225 tablets of bupropion hydrochloride 150 mg Tablet, Film Coated, Extended Release from Actavis Pharma, Inc., marketed since Aug 2025 and currently FDA-listed.

NDC 00591-3543-88
🏷️ FDA NDC (as labeled) 0591-3543-88 billing pads the labeler segment with a zero
This package
Contains33,225-count Pack sizes3 compare ↓
Product page 00591-3543-60 Also comes in: 60 tablets 0591-3543-60 60 tablets 0591-3543-76
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Bupropion Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 15, 2025 — Failed Tablet/Capsule Specifications (Graviti Pharmaceuticals Private Limited) · FDA recall D-0037-2026
Class II · Jun 24, 2024 — Failed Dissolution Specifications; the product is dissolving faster than the specified limits. (Amerisource Health Services LLC) · FDA recall D-0590-2024
Class II · Dec 29, 2023 — Presence of Foreign Tablets/Capsules (Rising Pharma Holding, Inc.) · FDA recall D-0222-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-3543-88
Product NDC 0591-3543
11-digit billing NDC 00591354388
SPL Set ID a591e33a-52f0-41c8-a00b-4a1afcc3dc4c
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-27
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance BUPROPION HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62100002107430
GPI class buPROPion HCl ER (Smoking Det)
GCN Seq No 031439
GCN 27901
HICL code 001653
Ingredient (HICL) Bupropion Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7N
Therapeutic class — specific (HIC3) Smoking Deterrents, Other
AHFS code 12:02.00.00
AHFS class Smoking Cessation Agents
FDB label name BUPROPION HCL SR 150 MG TABLET
FDB brand name Bupropion Hcl Sr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 031439
  • GCN: 27901
  • GPI-14 (Medi-Span): 62100002107430
  • HICL (First Databank): 001653
  • AHFS class code: 12:02.00.00
Why two NDCs? The FDA registers this code as 0591-3543-88 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00591-3543-88. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name BUPROPION HCL SR 150 MG TABLET Ingredient Bupropion Hcl
📖 What it is MedlinePlus · NLM

Bupropion is used to treat depression. and seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion is also used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bupropion treats major depressive disorder. Some extended-release products, like Aplenzin and bupropion XL, can also prevent seasonal affective disorder, the depression that return...
  • Take it by mouth exactly as prescribed. XL tablets are taken once in the morning, with or without food, and must be swallowed whole. Your doctor will usually raise the dose gradual...
  • The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, anxiety and tremor. Call your doctor right away if you have a seizure, new suicidal thoughts, sev...
  • It's best to limit or avoid alcohol. Rare neuropsychiatric events and lower alcohol tolerance have been reported. Never suddenly stop heavy drinking while on bupropion without talk...
📖 Read our full Bupropion guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Bupropion may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Bupropion nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 tablets 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00591-3543-60 0591-3543-60 Main listing 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC $0.2522 / ea $15.13 2009-06-11 — Active
00591-3543-76 0591-3543-76 1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC $0.2522 / ea $15.13 2009-08-25 — Active
00591-3543-88 You're viewing this 33225 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM — — — — Active

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 33,225-count package — 33225 tablet, film coated, extended release in 1 drum.
How does this package differ from NDC 00591-3543-60?
Both are bupropion hydrochloride 150 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 33,225-count one, while NDC 00591-3543-60 is the 60 tablets package.
What NDC number is used to bill for this package of bupropion hydrochloride 150 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bupropion Hydrochloride 150 mg 68001-0519-03 BluePoint 500 tablets $0.077 AB3 Availability likely —
Bupropion Hydrochloride (XL) 150 mg 24979-0101-02 Upsher-Smith 500 tablets $0.078 — Discontinued —
Bupropion Hydrochloride 150 mg 69097-0071-12 Cipla 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 00591-3331-05 Actavis 500 tablets $0.078 AB3 Availability likely —
Bupropion hydrochloride 150 mg 70010-0784-03 Granules 30 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 00904-7505-04 Major 1 tablet $0.078 AB3 Availability likely —
bupropion hydrochloride 150 mg 16571-0862-03 Rising 30 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 69367-0288-05 Westminster 500 tablets $0.078 AB3 Discontinued —
Bupropion Hydrochloride 150 mg 31722-0487-05 Camber 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 42806-0414-05 Epic 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride 150 mg 50268-0133-13 AvPAK 1 tablet $0.078 AB3 Availability likely —
Bupropion Hydrochloride (XL) 150 mg 50228-0144-05 ScieGen 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 68180-0319-02 Lupin 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride 150 mg 60687-0782-01 American 1 tablet $0.078 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 82009-0051-05 Quallent 500 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride (XL) 150 mg 83301-0024-01 Mullan 30 tablets $0.078 AB3 Availability likely —
Bupropion Hydrochloride 150 mg 16729-0443-10 Accord 30 tablets $0.078 AB3 Availability likely —
Bupropion hydrochloride 150 mg 63304-0723-05 Sun 500 tablets $0.079 — Discontinued —
Bupropion Hydrochloride XL 150 mg 42806-0348-05 Epic 500 tablets $0.079 AB3 Availability likely —
Bupropion Hydrochloride XL 150 mg 70436-0010-02 Slate 500 tablets $0.079 AB3 Availability likely —
Bupropion Hydrochloride 150 mg 59651-0847-01 Aurobindo 100 tablets $0.080 AB1 Availability likely —
Bupropion Hydrochloride SR 150 mg 00591-3541-05 Actavis 500 tablets $0.080 AB1 Availability likely —
Bupropion hydrochloride 150 mg 31722-0067-01 Camber 100 tablets $0.080 AB1 Availability likely —
Bupropion Hydrochloride SR 150 mg 42806-0425-01 Epic 100 tablets $0.080 AB1 Availability likely —
BuPROPion Hydrochloride 150 mg 68084-0708-25 American 1 tablet $0.080 AB1 Availability likely —
bupropion hydrochloride SR 150 mg 00904-7465-61 Major 1 tablet $0.080 AB1 Availability likely —
Bupropion Hydrochloride SR 150 mg 50228-0175-01 ScieGen 100 tablets $0.080 AB1 Availability likely —
Bupropion Hydrochloride SR 150 mg 43598-0752-01 Dr. 100 tablets $0.080 AB1 Availability likely —
Bupropion Hydrochloride 150 mg 42806-0415-01 Epic 100 tablets $0.082 AB1 Availability likely —
Bupropion Hydrochloride SR 150 mg 70436-0059-01 Slate 100 tablets $0.084 AB1 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 43598-0655-05 Dr 500 tablets $0.108 AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 69097-0875-02 CIPLA 30 tablets $0.119 — FDA listed —
Bupropion hydrochloride (XL) 150 mg 00527-2415-32 Lannett 30 tablets $0.119 AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 42806-0413-60 Epic 60 tablets $0.252 AB2 Availability likely —
bupropion hydrochloride 150 mgthis 00591-3543-88 Actavis 33225 tablets — — FDA listed —
Bupropion Hydrochloride (Sr) 150 mg 43598-0863-10 Dr. 1000 tablets — AB2 FDA listed —
Bupropion Hydrochloride SR 150 mg 50090-1150-00 A-S 60 tablets — AB2 FDA listed —
Bupropion Hydrochloride (Sr) 150 mg 50090-5101-00 A-S 60 tablets — AB2 FDA listed —
Bupropion Hydrochloride SR 150 mg 50090-7322-00 A-S 60 tablets — AB2 Discontinued —
Bupropion Hydrochloride (SR) 150 mg 50228-0338-11 ScieGen 1000 tablets — AB2 FDA listed —
Bupropion Hydrochloride 150 mg 47335-0954-13 Sun 500 tablets — — FDA listed —
Bupropion hydrochloride 150 mg 63187-0052-30 Proficient 30 tablets — — FDA listed —
Bupropion Hydrochloride 150 mg 63187-0713-30 Proficient 30 tablets — — FDA listed —
Bupropion Hydrochloride SR 150 mg 63187-0726-30 Proficient 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride (Sr) 150 mg 69097-0878-02 Cipla 30 tablets — — FDA listed —
Bupropion Hydrochloride XL 150 mg 71205-0291-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 71205-0394-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 71205-0504-30 Proficient 30 tablets — AB3 FDA listed —
bupropion 150 mg 71205-0565-30 Proficient 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 71205-0967-30 Proficient 30 tablets — — FDA listed —
Bupropion Hydrochloride SR 150 mg 71610-0576-30 Aphena 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 43598-0537-01 Dr. 100 tablets — AB1 FDA listed —
Bupropion Hydrochloride XL 150 mg 50090-4049-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 63187-0766-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 76282-0480-05 Exelan 500 tablets — — FDA listed —
Bupropion hydrochloride 150 mg 80425-0300-01 Advanced 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 82804-0080-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 82868-0097-96 Northwind 180 tablets — AB3 FDA listed —
Wellbutrin Xl 150 mg 00187-0730-07 Bausch 7 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 50090-5163-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 50090-7110-00 A-S 90 tablets — — FDA listed —
bupropion 150 mg 51655-0357-26 Northwind 90 tablets — AB1 FDA listed —
Bupropion Hydrochloride XL 150 mg 68071-3594-03 NuCare 30 tablets — AB3 FDA listed —
bupropion hydrochloride 150 mg 70518-4674-00 REMEDYREPACK 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 71335-2378-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 50090-4747-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 50090-6871-00 A-S 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride XL 150 mg 50090-7113-00 A-S 90 tablets — AB3 Discontinued —
Bupropion Hydrochloride 150 mg 50090-7712-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 63629-8474-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion hydrochloride 150 mg 70518-4081-01 REMEDYREPACK 30 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 70518-4189-00 REMEDYREPACK 30 tablets — AB3 FDA listed —
Bupropion hydrochloride 150 mg 71335-2457-01 Bryant 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 71610-0990-30 Aphena 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 72789-0120-90 PD-Rx 90 tablets — — Discontinued —
Bupropion Hydrochloride 150 mg 72789-0301-90 PD-Rx 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 77771-0144-05 RADHA 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 83008-0082-30 Quality 30 tablets — AB3 FDA listed —
bupropion hydrochloride SR 150 mg 55154-0183-00 Cardinal 1 tablet — AB1 FDA listed —
Bupropion hydrochloride 150 mg 68788-4010-01 Preferred 100 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 68788-7786-01 Preferred 100 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 70518-3963-00 REMEDYREPACK 30 tablets — AB3 Discontinued —
Bupropion Hydrochloride 150 mg 71335-1044-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 76420-0923-01 Asclemed 100 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 50090-7109-00 A-S 90 tablets — — FDA listed —
Bupropion Hydrochloride 150 mg 50090-7711-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 68071-3927-03 NuCare 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 68071-3932-03 NuCare 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 68788-7807-01 Preferred 100 tablets — AB1 FDA listed —
Bupropion Hydrochloride 150 mg 70010-0126-03 Granules 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride 150 mg 70518-2458-00 REMEDYREPACK 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 71335-1837-01 Bryant 60 tablets — AB1 FDA listed —
buPropion Hydrochloride XL 150 mg 72516-0035-03 Oryza 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 80425-0461-01 Advanced 30 tablets — AB3 FDA listed —
bupropion hydrochloride SR 150 mg 43547-0289-06 Solco 60 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 50090-7423-00 A-S 90 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 51655-0115-25 Northwind 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride XL 150 mg 72789-0377-90 PD-Rx 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 00615-8504-05 NCS 15 tablets — AB3 FDA listed —
Bupropion hydrochloride 150 mg 00615-8602-39 NCS 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride 150 mg 00115-6811-02 Amneal 500 tablets — — FDA listed —
Bupropion Hydrochloride Sr 150 mg 43063-0744-30 PD-Rx 30 tablets — — FDA listed —
Bupropion Hydrochloride 150 mg 50090-6353-00 A-S 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride XL 150 mg 51655-0098-26 Northwind 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 150 mg 67046-0699-03 Coupler 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 71335-0135-01 Bryant 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride 150 mg 72189-0134-30 DIRECT 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 50090-6872-00 A-S 90 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 63629-8473-01 Bryant 500 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 68788-8769-01 Preferred 100 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 71335-2469-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 50090-6789-00 A-S 90 tablets — AB3 FDA listed —
Bupropion hydrochloride (XL) 150 mg 69680-0157-30 Vitruvias 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 70518-2022-02 REMEDYREPACK 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 71335-1702-01 Bryant 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 72162-1529-05 Bryant 500 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 43063-0913-30 PD-Rx 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride (XL) 150 mg 72162-1526-05 Bryant 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 77771-0175-05 Radha 500 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 82804-0296-90 Proficient 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 82868-0019-60 Northwind 60 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 47335-0737-08 Sun 100 tablets — — FDA listed —
Bupropion Hydrochloride XL 150 mg 50090-7112-00 A-S 90 tablets — AB3 Discontinued —
Bupropion hydrochloride 150 mg 50090-7422-00 A-S 60 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 68071-2890-03 NuCare 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride 150 mg 68071-3559-09 NuCare 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride SR 150 mg 70518-4056-01 REMEDYREPACK 30 tablets — AB1 FDA listed —
Bupropion Hydrochloride SR 150 mg 71205-0550-30 Proficient 30 tablets — AB1 FDA listed —
Bupropion hydrochloride 150 mg 67046-1273-03 Coupler 30 tablets — AB1 FDA listed —
bupropion hydrochloride 150 mg 71335-3153-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 150 mg 59651-0511-05 Aurobindo 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride (SR) 150 mg 33342-0527-10 Macleods 90 tablets — AB1 FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintWPI;867
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 0A7M0N7SPE
    Hydroxypropyl cellulose is a plant-derived thickener made by chemically modifying cellulose. It acts as a binder to hold tablet ingredients together, a film-former for coatings, and a thickener in liquid formulations.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedAug 2025
Product typeDrug For Further Processing
Portfolio324 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 202 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS S UICIDALITY AND ANTIDEPRESSANT DRUGS Although bupropion hydrochloride extended-release tablets (SR) are not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN S R ® , and WELLBUTRIN XL ® . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [ see Warnings and Precautions ( 5.1 )] .

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions ( 5.1 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )

🎯 Indications and Usage 38 words ▾

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment. Bupropion hydrochloride extended-release tablets (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dose: 150 mg per day for first 3 days. ( 2.1 ) General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Begin dosing one week before quit day.

( 2.1 ) After 3 days, increase the dose to 300 mg per day, given as 150 mg twice daily at an interval of at least 8 hours. ( 2.1 ) May be used with a nicotine transdermal system. ( 2.5 ) Moderate to severe hepatic impairment: 150 mg every other day.

( 2.6 , 8.7 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6 , 8.7 ) Renal impairment: Consider reducing the dose and/or frequency. ( 2.7 , 8.6 )

2.1Usual Dosage Treatment with bupropion hydrochloride extended-release tablets (SR) should be initiated before the patient’s planned quit day, while the patient is still smoking, because it takes approximately 1 week of treatment to achieve steady-state blood levels of bupropion. The patient should set a “target quit date” within the first 2 weeks of treatment with bupropion hydrochloride extended-release tablets (SR). Dosing To minimize the risk of seizure: Begin dosing with one 150 mg tablet per day for 3 days.

Increase dose to 300 mg per day given as one 150 mg tablet twice each day with an interval of at least 8 hours between each dose. Do not exceed 300 mg per day. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures [see Warnings and Precautions ( 5.3 )] .

Bupropion hydrochloride extended-release tablets (SR) may be taken with or without food [see Clinical Pharmacology ( 12.3 )] .

2.2Duration of Treatment Treatment with bupropion hydrochloride extended-release tablets (SR) should be continued for 7 to 12 weeks. If the patient has not quit smoking after 7 to 12 weeks, it is unlikely that he or she will quit during that attempt so treatment with bupropion hydrochloride extended-release tablets (SR) should probably be discontinued and the treatment plan reassessed. The goal of therapy with bupropion hydrochloride extended-release tablets (SR) is complete abstinence.

Discuss discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) after 12 weeks if the patient feels ready but consider whether the patient may benefit from ongoing treatment. Patients who successfully quit after 12 weeks of treatment but do not feel ready to discontinue treatment should be considered for ongoing therapy with bupropion hydrochloride extended-release tablets (SR); longer treatment should be guided by the relative benefits and risks for individual patients. It is important that patients continue to receive counseling and support throughout treatment with bupropion hydrochloride extended-release tablets (SR) and for a period of time thereafter.

2.3Individualization of Therapy Patients are more likely to quit smoking and remain abstinent if they are seen frequently and receive support from their physicians or other healthcare professionals. It is important to ensure that patients read the instructions provided to them and have their questions answered. Physicians should review the patient’s overall smoking cessation program that includes treatment with bupropion hydrochloride extended-release tablets (SR).

Patients should be advised of the importance of participating in the behavioral interventions, counseling, and/or support services to be used in conjunction with bupropion hydrochloride extended-release tablets (SR) [see Medication Guide ] . Patients who fail to quit smoking during an attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who are unsuccessful should be evaluated to determine why they failed.

A new quit attempt should be encouraged when factors that contributed to failure can be eliminated or reduced, and conditions are more favorable.

2.4Maintenance Tobacco dependence is a chronic condition. S… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS 150 mg – white to off-white, round, bi-convex, film-coated tablets debossed with “WPI” over “867” on one side. Tablets: 150 mg. ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.3 )] . Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] .

The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (SR) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (SR) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (SR) within 14 days of discontinuing treatment with an MAOI is also contraindicated.

Starting bupropion hydrochloride extended-release tablets (SR) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.8 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.6 )] . Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (SR). Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see Warnings and Precautions ( 5.8 )] .

Seizure disorder. ( 4 , 5.3 ) Current or prior diagnosis of bulimia or anorexia nervosa. ( 4 , 5.3 ) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs.

( 4 , 5.3 ) Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride extended-release tablets (SR) or within 14 days of stopping treatment with bupropion hydrochloride extended-release tablets (SR). Do not use bupropion hydrochloride extended-release tablets (SR) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-release tablets (SR) in a patient who is being treated with linezolid or intravenous methylene blue.

( 4 , 7.6 ) Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (SR). ( 4 , 5.8 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Neuropsychiatric adverse events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion hydrochloride extended-release tablets (SR) for the occurrence of such symptoms and instruct them to discontinue bupropion hydrochloride extended-release tablets (SR) and contact a healthcare provider if they experience such adverse events.

( 5.2 ) Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 300 mg. Discontinue if seizure occurs.

( 4 , 5.3 , 7.3 ) Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment, especially if used with nicotine replacement. ( 5.4 ) Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms.

( 5.5 ) Psychosis and other neuropsychiatric reactions. Instruct patients to contact a healthcare professional if reactions occur. ( 5.6 ) Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.

( 5.7 )

5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Although bupropion hydrochloride extended-release tablets (SR) are not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders.

Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 subjects. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 subjects.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differe… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning , W arnings and Precautions ( 5.1 )] Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions ( 5.2 )] Seizure [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] Psychosis and other neuropsychiatric reactions [see Warnings and Precautions ( 5.6 )] Angle-closure glaucoma [see Warnings and Precautions ( 5.7 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence greater than or equal to 5% and greater than or equal to 1% more than placebo rate) are insomnia, rhinitis, dry mouth, dizziness, nervous disturbance, anxiety, nausea, constipation, and arthralgia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Ad v e r se Reactions Leading to Discontinuation of Treatment Adverse reactions were sufficiently troublesome to cause discontinuation of treatment in 8% of the 706 subjects treated with bupropion hydrochloride extended-release tablets (SR) and 5% of the 313 patients treated with placebo.

The more common events leading to discontinuation of treatment with bupropion hydrochloride extended-release tablets (SR) included nervous system disturbances (3.4%), primarily tremors, and skin disorders (2.4%), primarily rashes. Commonly Observed Adverse Reactions The most commonly observed adverse reactions consistently associated with the use of bupropion hydrochloride extended-release tablets (SR) were dry mouth and insomnia. The incidence of dry mouth and insomnia may be related to the dose of bupropion hydrochloride extended-release tablets (SR).

The occurrence of these adverse reactions may be minimized by reducing the dose of bupropion hydrochloride extended-release tablets (SR). In addition, insomnia may be minimized by avoiding bedtime doses. Adverse reactions reported in the dose-response and comparator trials are presented in Table 2 and Table 3, respectively.

Reported adverse reactions were classified using a COSTART-based dictionary. Table 2. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in the Dose-Response Trial Adverse Reaction Bupropion Hydrochloride Extended-Release Tablets (SR) 100 to 300 mg/day ( n = 461) % P lacebo ( n = 150) % Body (General) Neck pain 2 <1 Allergic reaction 1 0 Cardiovascular Hot flashes 1 0 Hypertension 1 <1 Digestive Dry mouth 11 5 Increased appetite 2 <1 Anorexia 1 <1 Musculoskeletal Arthralgia 4 3 Myalgia 2 1 Nervous system Insomnia 31 21 Dizziness 8 7 Tremor 2 1 Somnolence 2 1 Thinking abnormality 1 0 Respiratory Bronchitis 2 0 Skin Pruritus 3 <1 Rash 3 <1 Dry skin 2 0 Urticaria 1 0 Special senses Taste perversion 2 <1 Table 3.

Adverse Reactions Reported by at Least 1% of Subjects on Active Treatment and at a Greater Frequency than Placebo in the Comparator Trial Adverse Experience (COSTART Term) Bupropion Hydrochloride Extended-Release Tablets (SR) 300 mg/day ( n = 243) % Nicotine Transdermal System (NTS) 21 mg/day (n = 243) % Bupropion Hydrochloride Extended-Release Tablets (SR) and NTS (n = 244) % Placebo (n = 159) % Body Abdominal pain 3 4 1 1 Accidental injury 2 2 1 1 Chest pain <1 1 3 1 Neck pain 2 1 <1 0 Facial edema <1 0 1 0 Cardiovascular Hypertension 1 <1 2 0 Palpitations 2 0 1 0 Digestive Nausea 9 7 11 4 Dry mouth 10 4 9 4 Constipation 8 4 9 3 Diarrhe… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital and phenytoin) based on clinical response, but should not exceed the maximum recommended dose. ( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide).

Consider dose reduction when using with bupropion. ( 7.2 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.

( 7.2 ) Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (SR) with caution. ( 5.3 , 7.3 ) Dopaminergic drugs (levodopa and amantadine): Central nervous system (CNS) toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR). ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR).

( 7.6 ) Drug-laboratory test interactions: Bupropion hydrochloride extended-release tablets (SR) can cause false-positive urine test results for amphetamines. ( 7.8 )

7.1Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (SR) Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between bupropion hydrochloride extended-release tablets (SR) and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure.

Based on clinical response, dosage adjustment of bupropion hydrochloride extended-release tablets (SR) may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see Clinical Pharmacology ( 12.3 )] . Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz : Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of bupropion hydrochloride extended-release tablets (SR) may be necessary when coadministered with ritonavir, lopinavir, or efavirenz [see Clinical Pharmacology ( 12.3 )] but should not exceed the maximum recommended dose.

Carbamazepine, Phenobarbital, Phenytoin: While not systematically studied, these drugs may induce the metabolism of bupropion and may decrease bupropion exposure [see Clinical Pharmacology ( 12.3 )] . If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded.

7.2Potential for Bupropion Hydrochloride Extended-Release Tablets (SR) to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of bupropion hydrochloride extended-release tablets (SR) with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone and flecainide).

When used concomitantly with bupropion hydrochloride extended-release tablets (SR), it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index. Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors o… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if benefit outweighs potential risk to the fetus. ( 8.1 )

8.1Pregnancy Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (MRHD) and greater and decreased fetal weights were seen at doses three times the MRHD and greater.

Bupropion hydrochloride extended-release tablets (SR) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before pharmacological approaches are used. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall.

No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.

Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association.

The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n = 17; adjusted OR = 2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies.

An imal Data: In studies conducted in rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg per kg per day, respectively (approximately 15 and 10 times the MRHD respectively, on a mg per m 2 basis). No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (MRHD) and greater and decreased fetal weights were seen at doses three times the MRHD and greater.

Bupropion hydrochloride extended-release tablets (SR) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before pharmacological approaches are used. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall.

No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.

Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association.

The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n = 17; adjusted OR = 2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies.

An imal Data: In studies conducted in rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg per kg per day, respectively (approximately 15 and 10 times the MRHD respectively, on a mg per m 2 basis). No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg per kg per day, approximately 2 times the MRHD on a mg per m 2 basis) and… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established [see Boxed Warning , Warnings and Precautions ( 5.1 )].

🧓 Geriatric Use 192 words ▾

8.5Geriatric Use Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged greater than or equal to 65 years and 47 were aged greater than or equal to 75 years. In addition, several hundred subjects aged greater than or equal to 65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see Dosage and Administration ( 2.7 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 192 words ▾

10 OVERDOSAGE

10.1Human Overdose Experience Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one-third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias, clonus, myoclonus, and hyperreflexia.

Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

10.2Overdosage Management Consult a Certified Poison Control Center for up–to-date guidance and advice. Call 1-800-222-1222 or refer to www.poison.org. There are no known antidotes for bupropion.

In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation.

Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The exact mechanism by which bupropion hydrochloride extended-release tablets (SR) enhances the ability of patients to abstain from smoking is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.

Ab sorption The absolute bioavailability of bupropion hydrochloride extended-release tablets (SR) in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. In rat and dog studies, the bioavailability of bupropion ranged from 5% to 20%.

In humans, following oral administration of bupropion hydrochloride extended-release tablets (SR), peak plasma concentration (C max ) of bupropion is usually achieved within 3 hours. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food. Bupropion C max and AUC were increased by 11% to 35%, and 16% to 19%, respectively, when bupropion hydrochloride extended-release tablets (SR) was administered with food to healthy volunteers in three trials.

The food effect is not considered clinically significant. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg per mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion; whereas, the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion.

M e tabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert -butyl group of bupropion, and the amino-alcohol isomers, threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion.

Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one-half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion.

This may be of clinical importance, because the plasma concentrations of the metabolites are as high as or higher than those of bupropion. Following a single-dose administration of bupropion hydrochloride extended-release tablets (SR) in humans, C max of hydroxybupropion occurs approximately 6 hours post-dose and is approximately 10 times the peak level of the parent drug at steady state. The elimination half-life of hydroxybupropion is approximately 20 (±5) hours and its AUC at steady state is about 17 times that of bupropion.

The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.5 and 7 times that of bupropion, respectively. Bupropion and its metabolites exhibit linea… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 65 words ▾

12.1Mechanism of Action The exact mechanism by which bupropion hydrochloride extended-release tablets (SR) enhances the ability of patients to abstain from smoking is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

📦 How Supplied / Storage and Handling 72 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets USP (SR), 150 mg of bupropion hydrochloride, USP are white to off-white, round, bi-convex, film-coated tablets debossed with “WPI” over “867” on one side and supplied in bottles of 60 tablets (NDC 0591-3543-60) and the Starter Pack containing 1 bottle of 60 tablets (NDC 0591-3543-76). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

📋 Description 204 words ▾

11 DESCRIPTION Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion hydrochloride extended-release tablets, USP (SR) are chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN ® [bupropion hydrochloride] tablets and WELLBUTRIN SR ® [bupropion hydrochloride] sustained-release tablets), bupropion hydrochloride extended-release tablets, USP (SR) are also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.

Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2.

The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa.

The structural formula is: Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150 mg white to off-white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and stearic acid. The film-coating contains hydroxypropyl cellulose, lactose monohydrate, polyethylene glycol, and titanium dioxide. bupropion hydrochloride chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or healthcare professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning , Warnings and Precautions ( 5.1 )] .

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion hydrochloride extended-release tablets (SR). Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] .

Se v e r e Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (SR) if they have a severe allergic reaction to bupropion hydrochloride extended-release tablets (SR). Se izure Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and not restart it if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure.

Advise patients to minimize or avoid use of alcohol. Angle-Closure Glaucoma Patients should be advised that taking bupropion hydrochloride extended-release tablets (SR) can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy.

Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.7 )] . Bup ro p ion-Containing Products Educate patients that bupropion hydrochloride extended-release tablets (SR) contains the same active ingredient (bupropion hydrochloride) found in WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® , which are used to treat depression and that bupropion hydrochloride extended-release tablets (SR) should not be used in conjunction with any other medications that contain bupropion (such as WELLBUTRIN ® , the immediate-release formulation; WELLBUTRIN SR ® , the sustained-release formulation; WELLBUTRIN XL ® or FORFIVO XL ® , the extended-release formulations; and APLENZIN ® , the extended-release formulation of bupropion hydrobromide).

In addition, there are a number of generic bupropion HCl products for the immediate-, sustained-, and extended-release formulations. Po tential for Cognitive and Motor Impairment Advise patients that… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE BuPROPion Hydrochloride ( bue proe' pee on hye" droe klor' ide) Extended-Release Tablets (SR) IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?” Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking.

Talk to your healthcare provider or your family member’s healthcare provider about: all risks and benefits of quit-smoking medicines. all treatment choices for quitting smoking. When you try to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR), you may have symptoms that may be due to nicotine withdrawal, including: urge to smoke frustration restlessness depressed mood anger decreased heart rate trouble sleeping feeling anxious increased appetite irritability difficulty concentrating weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication.

Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking bupropion hydrochloride extended-release tablets (SR) to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion hydrochloride extended-release tablets (SR), and others developed them after several weeks of treatment, or after stopping bupropion hydrochloride extended-release tablets (SR).

These symptoms happened more often in people who had a history of mental health problems before taking bupropion hydrochloride extended-release tablets (SR) than in people without a history of mental health problems. Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider right away if you, your family, or caregiver notices any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (SR).

In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (SR), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets (SR), tell your healthcare provider if you have ever had depression or other mental health problems.

You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR). Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions Although bupropion hydrochloride extended-release tablets (SR) are not a treatment for depression, it contains bupropion, the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® .

This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. What is the most important information I should know about antidepressant medicines, dep… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 72 words ▾

8.3Nursing Mothers Bupropion and its metabolites are present in human milk. In a lactation study of 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. The average daily infant exposure (assuming 150 mL per kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose.

Exercise caution when bupropion hydrochloride extended-release tablets (SR) are administered to a nursing woman.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.

Ab sorption The absolute bioavailability of bupropion hydrochloride extended-release tablets (SR) in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. In rat and dog studies, the bioavailability of bupropion ranged from 5% to 20%.

In humans, following oral administration of bupropion hydrochloride extended-release tablets (SR), peak plasma concentration (C max ) of bupropion is usually achieved within 3 hours. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food. Bupropion C max and AUC were increased by 11% to 35%, and 16% to 19%, respectively, when bupropion hydrochloride extended-release tablets (SR) was administered with food to healthy volunteers in three trials.

The food effect is not considered clinically significant. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg per mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion; whereas, the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion.

M e tabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert -butyl group of bupropion, and the amino-alcohol isomers, threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion.

Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one-half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion.

This may be of clinical importance, because the plasma concentrations of the metabolites are as high as or higher than those of bupropion. Following a single-dose administration of bupropion hydrochloride extended-release tablets (SR) in humans, C max of hydroxybupropion occurs approximately 6 hours post-dose and is approximately 10 times the peak level of the parent drug at steady state. The elimination half-life of hydroxybupropion is approximately 20 (±5) hours and its AUC at steady state is about 17 times that of bupropion.

The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.5 and 7 times that of bupropion, respectively. Bupropion and its metabolites exhibit linear kinetics following chronic administration of 300 to 450 mg per day.

E limination Following oral administration of 200 mg of 14 C-bupropion in humans, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively. Only 0.5% of the oral dose was excreted as unchanged bupropion. Specific Populations Factors or conditions altering metabolic capacity (e.g., liver disease, congestive heart failure [CHF], age, concomitant medications, etc.) or elimi… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of bupropion hydrochloride extended-release tablets (SR) as an aid to smoking cessation was demonstrated in 3 placebo-controlled, double-blind trials in nondepressed chronic cigarette smokers (n = 1,940, greater than or equal to 15 cigarettes per day). In these trials, bupropion hydrochloride extended-release tablets (SR) were used in conjunction with individual smoking cessation counseling. The first trial was a dose-response trial conducted at 3 clinical centers.

Subjects in this trial were treated for 7 weeks with 1 of 3 doses of bupropion hydrochloride extended-release tablets (SR) (100, 150, or 300 mg per day) or placebo; quitting was defined as total abstinence during the last 4 weeks of treatment (Weeks 4 through 7). Abstinence was determined by subject daily diaries and verified by carbon monoxide levels in expired air. Results of this dose-response trial with bupropion hydrochloride extended-release tablets (SR) demonstrated a dose-dependent increase in the percentage of subjects able to achieve 4-week abstinence (Weeks 4 through 7).

Treatment with bupropion hydrochloride extended-release tablets (SR) at both 150 and 300 mg per day was significantly more effective than placebo in this trial. Table 5 presents quit rates over time in the multicenter trial by treatment group. The quit rates are the proportions of all subjects initially enrolled (i.e., intent-to-treat analysis) who abstained from Week 4 of the trial through the specified week.

Treatment with bupropion hydrochloride extended-release tablets (SR) (150 or 300 mg per day) was more effective than placebo in helping subjects achieve 4-week abstinence. In addition, treatment with bupropion hydrochloride extended-release tablets (SR) (7 weeks at 300 mg per day) was more effective than placebo in helping subjects maintain continuous abstinence through Week 26 (6 months) of the trial. Table 5.

Dose-Response Trial: Quit Rates by Treatment Group Abstinence from Week 4 through Specified Week Treatment Groups Placebo (n = 151) % (95% CI) Bupropion Hydrochloride Extended-Release Tablets (SR) 100 mg/day ( n = 153) % (95% CI) Bupropion Hydrochloride Extended-Release Tablets (SR) 150 mg/day ( n = 153) % (95% CI) Bupropion Hydrochloride Extended-Release Tablets (SR) 300 mg/day ( n = 156) % (95% CI) Week 7 (4-week quit) 17% (11 to 23) 22% (15 to 28) 27% a (20 to 35) 36% a (28 to 43) Week 12 14% (8 to 19) 20% (13 to 26) 20% (14 to 27) 25% a (18 to 32) Week 26 11% (6 to 16) 16% (11 to 22) 18% (12 to 24) 19% a (13 to 25) a Significantly different from placebo ( P ≤0.05).

The second trial was a comparator trial conducted at 4 clinical centers. Four treatments were evaluated: bupropion hydrochloride extended-release tablets (SR) 300 mg per day, nicotine transdermal system (NTS) 21 mg per day, combination of bupropion hydrochloride extended-release tablets (SR) 300 mg per day plus NTS 21 mg per day, and placebo. Subjects were treated for 9 weeks.

Treatment with bupropion hydrochloride extended-release tablets (SR) was initiated at 150 mg per day while the subject was still smoking and was increased after 3 days to 300 mg per day given as 150 mg twice daily. NTS 21 mg per day was added to treatment with bupropion hydrochloride extended-release tablets (SR) after approximately 1 week when the subject reached the target quit date. During Weeks 8 and 9 of the trial, NTS was tapered to 14 and 7 mg per day, respectively.

Quitting, defined as total abstinence during Weeks 4 through 7, was determined by subject daily diaries and verified by expired air carbon monoxide levels. In this trial, subjects treated with any of the 3 treatments achieved greater 4-week abstinence rates than subjects treated with placebo. Table 6 presents quit rates over time by treatment group for the comparator trial.

Table 6. Comparator Trial: Quit Rates by Treatment Group Abstinence from Week 4 through Specified Week Treatment Groups Placebo (n = 160) % (95% CI) Nicotine Transder… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Bupropion is not a controlled substance.

9.2Abuse Humans Controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, often typical of central stimulant activity. In a population of individuals experienced with drugs of abuse, a single oral dose of 400 mg of bupropion produced mild amphetamine-like activity as compared with placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI) and a score greater than placebo but less than 15 mg of the Schedule II stimulant dextroamphetamine on the Liking Scale of the ARCI.

These scales measure general feelings of euphoria and drug liking which are often associated with abuse potential. Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or CNS stimulant abusers.

However, higher doses (which could not be tested because of the risk of seizure) might be modestly attractive to those who abuse CNS stimulant drugs. Bupropion hydrochloride extended-release tablets (SR) are intended for oral use only. The inhalation of crushed tablets or injection of dissolved bupropion has been reported.

Seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. An imals Studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule-controlled behavior paradigms.

In primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. In rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs. The possibility that bupropion may induce dependence should be kept in mind when evaluating the desirability of including the drug in smoking cessation programs of individual patients.

🔒 Controlled Substance 9 words ▾

9.1Controlled Substance Bupropion is not a controlled substance.

🧪 Nonclinical Toxicology 203 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg per kg per day, respectively. These doses are approximately 10 and 2 times the MRHD, respectively, on a mg per m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg per kg per day (approximately 3 to 10 times the MRHD on a mg per m 2 basis); lower doses were not tested.

The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity assay.

Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. A fertility study in rats at doses up to 300 mg per kg per day revealed no evidence of impaired fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 200 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg per kg per day, respectively. These doses are approximately 10 and 2 times the MRHD, respectively, on a mg per m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg per kg per day (approximately 3 to 10 times the MRHD on a mg per m 2 basis); lower doses were not tested.

The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity assay.

Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. A fertility study in rats at doses up to 300 mg per kg per day revealed no evidence of impaired fertility.

📄 Package Label / Principal Display Panel 151 words ▾

PRINCIPAL DISPLAY PANEL NDC 0591-3543-60 Twice-A-Day (After Initial Titration) BuPROPion HCl Extended-Release Tablets, USP (SR) 150 mg WARNING: Do not use in combination with Wellbutrin ® ,Wellbutrin SR ® , Wellbutrin XL ® or any other medicines that contain bupropion hydrochloride. Federal Law requires dispensing of BuPROPion HCl Extended Release Tablets, USP (SR) with the Medication Guide. Rx only 60 Tablets 1 1

PRINCIPAL DISPLAY PANEL NDC 0591-3543-76 Prescription medicine for smoking cessation. Twice-A-Day (After Initial Titration) Rx only BuPROPion HCl Extended-Release Tablets, USP (SR) 150 mg Starter Pack Each extended-release tablet contains 150 mg of bupropion hydrochloride. Now you have what it takes to help you quit smoking.

Includes - 1 bottle of 60 tablets Plan to Succeed Workbook Federal Law requires dispensing of BuPROPion HCl Extended-Release Tablets, USP (SR) with the Medication Guide. WARNING: Do not use with medicines that contain buproprion HCl. 1 bottle of 60 Tablets 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets00591-3543-60 4,320 Rx · $99,230
60 tablets00591-3543-76 119 Rx · $2,571
33225 tablets this page00591-3543-88 No Medicaid data
Drug total (last 4 qtrs): 4,439 Rx · 235,838 units · $101,800 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (00591-3543-60), 60 tablets (00591-3543-76). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00591-3542-60 · Actavis 00591-3636-05 · Actavis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.