Home › NDC Lookup › Ingredients › Bupropion Hydrochloride › 68084-0708-25

BuPROPion Hydrochloride 150 mg Tablet, Film Coated, Extended Release

by American Health Packaging · 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-708-25) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-708-95)

NDC 68084-0708-25

🏷️ FDA NDC (as labeled) 68084-708-25 billing pads the product segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 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 Dr. Brian Staiger, PharmD

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

FDA NDC (as labeled) 68084-708-25

Product NDC 68084-708

11-digit billing NDC 68084070825

NCPDP billing unit EA — each (per item)

RxCUI 993503, 993518

UNII ZG7E5POY8O

Application # ANDA079095

SPL Set ID 1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8

Established class (EPC) Aminoketone

Mechanism of action Dopamine Uptake Inhibitors; Norepinephrine Uptake Inhibitors

Physiologic effect Increased Dopamine Activity; Increased Norepinephrine Activity

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-04-01

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance BUPROPION HYDROCHLORIDE

GCN Seq No 046238

GCN 16386

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 H7D

Therapeutic class — specific (HIC3) Norepinephrine And Dopamine Reuptake Inhib (Ndris)

AHFS code 28:16.04.92

AHFS class Antidepressants, Miscellaneous

FDB label name BUPROPION HCL SR 150 MG TABLET

FDB brand name Bupropion Hcl Sr

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB1 · RLD · RS

Why two NDCs? The FDA registers this code as 68084-708-25 — a 5-3-2 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 product segment → 68084-0708-25. 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.

🏷️ RxNorm drug class

This medicine belongs to the Aminoketone class.

Pharmacologic class Aminoketone

Drug family (ATC) Centrally acting antiobesity products, Other antidepressants

How it works Norepinephrine Uptake Inhibitors, Dopamine Uptake Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmerican Health Packaging

Application holderACTAVIS LABORATORIES FL INC

FDA applicationANDA079095 (ANDA)

Labeler code68084

First marketedApr 2015

Product typeHuman Prescription Drug

Portfolio673 products on file

🔎 All NDCs from American Health Packaging

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.

🩺 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 is an antidepressant primarily used to treat major depressive disorder — that's clinical depression. Depending on which formulation you're prescribed, it may also be used...
Most people don't notice a full effect immediately — antidepressant treatment for depression typically requires several months or longer. Your dose may also be increased gradually...
Will bupropion make me feel better right away?
The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, and feeling anxious or agitated — especially early on. Many of these improve as your body adjusts...

📖 Read our full Bupropion guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

SODIUM Moderate Depletion

🧪 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.

💊 What it looks like

Color white

ShapeRound

ImprintWPI;839

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 RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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.

8 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.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.082	$2.47 / 30 tablet
Medicaid paysCMS SDUD · 12 mo	$0.5700	$17.10 / 30 tablet
Medicare drug plans payPart D · Q2 2026	$0.1526	$4.58 / 30 tablet

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 15% over the last 24 months.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Bupropion Hydrochloride 150 mg 68001-0519-03	BluePoint	500 tablets	$0.077	AB3	Availability likely	save 7%
Bupropion Hydrochloride (XL) 150 mg 24979-0101-02	Upsher-Smith	500 tablets	$0.078	—	Discontinued	save 5%
Bupropion hydrochloride 150 mg 63304-0723-05	Sun	500 tablets	$0.079	—	Discontinued	save 5%
Bupropion Hydrochloride XL 150 mg 42806-0348-05	Epic	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride 150 mg 69097-0071-12	Cipla	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 00591-3331-05	Actavis	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion hydrochloride 150 mg 70010-0784-03	Granules	30 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 00904-7505-04	Major	1 tablet	$0.079	AB3	Availability likely	save 4%
bupropion hydrochloride 150 mg 16571-0862-03	Rising	30 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 69367-0288-05	Westminster	500 tablets	$0.079	AB3	Discontinued	save 4%
Bupropion Hydrochloride 150 mg 31722-0487-05	Camber	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 42806-0414-05	Epic	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride 150 mg 50268-0133-13	AvPAK	1 tablet	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride (XL) 150 mg 50228-0144-05	ScieGen	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 68180-0319-02	Lupin	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride 150 mg 60687-0782-01	American	1 tablet	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 82009-0051-05	Quallent	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride (XL) 150 mg 83301-0024-01	Mullan	30 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride 150 mg 16729-0443-10	Accord	30 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride XL 150 mg 70436-0010-02	Slate	500 tablets	$0.079	AB3	Availability likely	save 4%
Bupropion Hydrochloride SR 150 mg 00591-3541-05	Actavis	500 tablets	$0.082	AB1	Availability likely	—
bupropion hydrochloride SR 150 mg 00904-7465-61	Major	1 tablet	$0.082	AB1	Availability likely	—
Bupropion hydrochloride 150 mg 31722-0067-01	Camber	100 tablets	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride 150 mg 42806-0415-01	Epic	100 tablets	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride SR 150 mg 42806-0425-01	Epic	100 tablets	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride SR 150 mg 43598-0752-01	Dr.	100 tablets	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride SR 150 mg 50228-0175-01	ScieGen	100 tablets	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride 150 mg 59651-0847-01	Aurobindo	100 tablets	$0.082	AB1	Availability likely	—
BuPROPion Hydrochloride 150 mgthis 68084-0708-25	American	1 tablet	$0.082	AB1	Availability likely	—
Bupropion Hydrochloride SR 150 mg 70436-0059-01	Slate	100 tablets	$0.084	AB1	FDA listed	+2%
Bupropion Hydrochloride (XL) 150 mg 43598-0655-05	Dr	500 tablets	$0.108	AB3	FDA listed	+31%
Bupropion Hydrochloride (XL) 150 mg 69097-0875-02	CIPLA	30 tablets	$0.119	—	FDA listed	+45%
Bupropion hydrochloride (XL) 150 mg 00527-2415-32	Lannett	30 tablets	$0.119	AB3	FDA listed	+45%
Bupropion Hydrochloride SR 150 mg 00591-3543-60	Actavis	60 tablets	$0.251	AB2	Availability likely	+205%
Bupropion Hydrochloride SR 150 mg 42806-0413-60	Epic	60 tablets	$0.251	AB2	Availability likely	+205%
Wellbutrin Sr 150 mg 00173-0135-55	GlaxoSmithKline	60 tablets	$7.514	AB1	Availability likely	+9021%
Bupropion hydrochloride 150 mg 00615-8602-39	NCS	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride Sr 150 mg 43063-0744-30	PD-Rx	30 tablets	—	—	FDA listed	—
Bupropion Hydrochloride SR 150 mg 43063-0913-30	PD-Rx	30 tablets	—	AB1	FDA listed	—
bupropion hydrochloride SR 150 mg 43547-0289-06	Solco	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 43598-0537-01	Dr.	100 tablets	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 47335-0737-08	Sun	100 tablets	—	—	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-6353-00	A-S	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 50090-6871-00	A-S	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 50090-6872-00	A-S	90 tablets	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 50090-7422-00	A-S	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 150 mg 51655-0357-26	Northwind	90 tablets	—	AB1	FDA listed	—
bupropion hydrochloride SR 150 mg 55154-0183-00	Cardinal	1 tablet	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 63187-0052-30	Proficient	30 tablets	—	—	FDA listed	—
Bupropion Hydrochloride SR 150 mg 63187-0726-30	Proficient	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 63629-8473-01	Bryant	500 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 68071-2890-03	NuCare	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 68788-7807-01	Preferred	100 tablets	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 68788-8769-01	Preferred	100 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride (Sr) 150 mg 69097-0878-02	Cipla	30 tablets	—	—	FDA listed	—
Bupropion Hydrochloride 150 mg 70010-0126-03	Granules	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 70518-4056-01	REMEDYREPACK	30 tablets	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 70518-4081-01	REMEDYREPACK	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71205-0550-30	Proficient	30 tablets	—	AB1	FDA listed	—
bupropion 150 mg 71205-0565-30	Proficient	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71335-0135-01	Bryant	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71335-1702-01	Bryant	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71335-1837-01	Bryant	60 tablets	—	AB1	FDA listed	—
Bupropion hydrochloride 150 mg 71335-2457-01	Bryant	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71610-0576-30	Aphena	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 71610-0990-30	Aphena	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 72162-1529-05	Bryant	500 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride Sr 150 mg 72189-0349-30	DirectRx	30 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 77771-0175-05	Radha	500 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride SR 150 mg 82868-0019-60	Northwind	60 tablets	—	AB1	FDA listed	—
Bupropion Hydrochloride 150 mg 47335-0954-13	Sun	500 tablets	—	—	FDA listed	—
Bupropion Hydrochloride (SR) 150 mg 50228-0338-11	ScieGen	1000 tablets	—	AB2	FDA listed	—
Bupropion Hydrochloride 150 mg 63187-0713-30	Proficient	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 Hydrochloride (XL) 150 mg 71205-0967-30	Proficient	30 tablets	—	—	FDA listed	—
Bupropion Hydrochloride SR 150 mg 50090-1150-00	A-S	60 tablets	—	AB2	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 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 (Sr) 150 mg 43598-0863-10	Dr.	1000 tablets	—	AB2	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-4747-00	A-S	90 tablets	—	AB3	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 70518-4189-00	REMEDYREPACK	30 tablets	—	AB3	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 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 (Sr) 150 mg 50090-5101-00	A-S	60 tablets	—	AB2	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 150 mg 70518-2458-00	REMEDYREPACK	90 tablets	—	AB3	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 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 00115-6811-02	Amneal	500 tablets	—	—	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 150 mg 72189-0134-30	DIRECT	30 tablets	—	AB3	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 50090-7322-00	A-S	60 tablets	—	AB2	Discontinued	—
Bupropion Hydrochloride (XL) 150 mg 72162-1526-05	Bryant	500 tablets	—	AB3	FDA listed	—
Bupropion hydrochloride 150 mg 82804-0296-90	Proficient	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 50090-7112-00	A-S	90 tablets	—	AB3	Discontinued	—
Bupropion Hydrochloride 150 mg 68071-3559-09	NuCare	90 tablets	—	AB3	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	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2015

On the market since

Apr 2015

📍

2026

Currently FDA-listed

11 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68084-0708-25, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

Units reimbursed last 4 qtrs

Gross reimbursed last 4 qtrs

$23.94

Avg / prescription

$1.50

Avg / unit

$0.5700

Latest quarter Q4 2025

0Rx

Medicaid pays / ea

$0.5700

gross reimbursed

NADAC / ea

$0.0824

acquisition cost

Spread

+$0.4876

+592% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 16 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.90.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Kentucky 0.9 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bupropion Hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea9,849

Headache8,210

Fatigue7,777

Depression6,630

Dizziness6,376

Anxiety6,235

Pain5,438

Reporter sex

Male · 26%

Female · 74%

Unknown · 0%

Serious outcomes

Death4,782

Disabling2,777

Life-threatening2,599

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
68084-0708-25 You're viewing this	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-708-25) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-708-95)	2015-04-01	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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

🚨 Boxed Warning 159 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS 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 118 words ▾

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM ) . The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14) ]. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14) ].

Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dose: 150 mg/day. ( 2.1 ) General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice daily at an interval of at least 8 hours.

( 2.1 ) Usual target dose: 300 mg/day as 150 mg twice daily. ( 2.1 ) Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients not responding to 300 mg/day. ( 2.1 ) Periodically reassess the dose and need for maintenance treatment.

( 2.1 ) Moderate to severe hepatic impairment: 100 mg daily or 150 mg every other day. ( 2.2 , 8.7 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 8.7 ) Renal impairment: Consider reducing the dose and/or frequency.

( 2.3 , 8.6 )

2.1General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (SR) may be taken with or without food.

The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Initiate dosing with 150 mg/day given as a single daily dose in the morning. After 3 days of dosing, the dose may be increased to the 300-mg/day target dose, given as 150 mg twice daily.

There should be an interval of at least 8 hours between successive doses. A maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day. To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any single dose.

It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of bupropion hydrochloride extended-release tablets (SR) needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

2.2Dose Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of bupropion hydrochloride extended-release tablets (SR) is 100 mg/day or 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ].

2.3Dose Adjustment in Patients with Renal Impairment Consider reducing the dose and/or frequency of bupropion hydrochloride extended-release tablets (SR) in patients with renal impairment (Glomerular Filtration Rate [GFR] less than 90 mL/min) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ].

2.4Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with bupropion hydrochloride extended-release tablets (SR). Conversely, at least 14 days should be allowed after stopping bupropion hydrochloride extended-release tablets (SR) before starting an MAOI antidepressant [see Contraindications (4) , Drug Interactions (7.6) ].

2.5Use of Bupropion Hydrochloride Extended-release Tablets (SR) with Reversible MAOIs Such as Linezolid or Methylene Blue Do not start bupropion hydrochloride extended-release tablets (SR) in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered [see…

💊 Dosage Forms and Strengths 80 words ▾

3 DOSAGE FORMS AND STRENGTHS Bupropion hydrochloride extended-release tablets, USP (SR) are available as follows: 100 mg – white to off-white, round, bi-convex, film-coated tablets debossed with “WPI" over "858” on one side. 150 mg – white to off-white, round, bi-convex, film-coated tablets debossed with “WPI" over "839” on one side. 200 mg – white to off-white, round, bi-convex, film-coated tablets debossed with “WPI" over "3385” on one side.

Extended-Release Tablets: 100 mg, 150 mg, 200 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 (2.4 , 2.5 ), Warnings and Precautions (5.4) , Drug Interactions (7.6) ]. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with 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 during smoking cessation: 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 for the occurrence of such symptoms and instruct them to discontinue bupropion 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 400 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. ( 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 such 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 Patients with 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 differences (drug vs. placebo), however, were relatively stable within age strata and across indications.

These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 subjects treated) are provided in Table 1. Table 1. Risk Differences in the Number of Suicidality Cases by Age Group in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Subjects Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Subjects Treated Increa…

🤒 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 , Warnings and Precautions (5.1) ] Neuropsychiatric symptoms 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 ≥5% and ≥2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia.

( 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. Adverse Reactions Leading to Discontinuation of Treatment In placebo‑controlled clinical trials, 4%, 9%, and 11% of the placebo, 300-mg/day, and 400-mg/day groups, respectively, discontinued treatment due to adverse reactions.

The specific adverse reactions leading to discontinuation in at least 1% of the 300-mg/day or 400-mg/day groups and at a rate at least twice the placebo rate are listed in Table 2. Table 2. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials Adverse Reaction Placebo (n = 385) Bupropion Hydrochloride Extended-release Tablets (SR) 300 mg/day (n = 376) Bupropion Hydrochloride Extended-release Tablets (SR) 400 mg/day (n = 114) Rash 0.0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0.0% 1.8% Commonly Observed Adverse Reactions Adverse reactions from Table 3 occurring in at least 5% of subjects treated with bupropion hydrochloride extended-release tablets (SR) and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups.

Bupropion hydrochloride extended-release tablets (SR) 300 mg/day: Anorexia, dry mouth, rash, sweating, tinnitus, and tremor. Bupropion hydrochloride extended-release tablets (SR) 400 mg/day: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Adverse reactions reported in placebo-controlled trials are presented in Table 3.

Reported adverse reactions were classified using a COSTART-based Dictionary. Table 3. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials — Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of subjects.

Body System/ Adverse Reaction Bupropion Hydrochloride Extended-release Tablets (SR) 300 mg/day (n = 376) Bupropion Hydrochloride Extended-release Tablets (SR) 400 mg/day (n = 114) Placebo (n = 385) Body (general) Headache 26% 25% 23% Infection 8% 9% 6% Abdominal pain 3% 9% 2% Asthenia 2% 4% 2% Chest pain 3% 4% 1% Pain 2% 3% 2% Fever 1% 2% — Cardiovascular Palpitation 2% 6% 2% Flushing 1% 4% — Migraine 1% 4% 1% Hot flashes 1% 3% 1% Digestive Dry mouth 17% 24% 7% Nausea 13% 18% 8% Constipation 10% 5% 7% Diarrhea 5% 7% 6% Anorexia 5% 3% 2% Vomiting 4% 2% 2% Dysphagia 0% 2% 0% Musculoskeletal Myalgia 2% 6% 3% Arthralgia 1% 4% 1% Arthritis 0% 2% 0% Twitch 1% 2% — Nervous system Insomnia 11% 16% 6% Dizziness 7% 11% 5% Agitation 3% 9% 2% Anxiety 5% 6% 3% Tremor 6% 3% 1% Nervousness 5% 3% 3%…

🔄 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): 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. ( 7.7 )

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 of CYP2D6 such as bupropion. Pa…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ . Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data) .

There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations) . When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 11 times the maximum recommended human dose (MRHD) of 400 mg/day. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately equal to the MRHD and greater.

Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data) . The estimated background risk for major birth defects and miscarriage is unknown for the indicated population. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. 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. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.

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, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use 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:…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use 23 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 173 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 ≥65 years and 47 were aged ≥75 years. In addition, several hundred subjects aged ≥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 (2.3) , Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ].

🆘 Overdosage 193 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 of the antidepressant action of bupropion 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.

Absorption 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. In a trial comparing chronic dosing with bupropion hydrochloride extended-release tablets (SR) 150 mg twice daily to bupropion immediate-release formulation 100 mg 3 times daily, the steady state C max for bupropion after bupropion hydrochloride extended-release tablets (SR) administration was approximately 85% of those achieved after bupropion immediate-release formulation administration.

Exposure (AUC) to bupropion was equivalent for both formulations. Bioequivalence was also demonstrated for all three major active metabolites (i.e., hydroxybupropion, threohydrobupropion and erythrohydrobupropion) for both C max and AUC. Thus, at steady state, bupropion hydrochloride extended-release tablets (SR) given twice daily, and the immediate-release formulation of bupropion given 3 times daily, are essentially bioequivalent for both bupropion and the 3 quantitatively important metabolites.

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/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. Metabolism 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…

🧬 Mechanism of Action 55 words ▾

📦 How Supplied / Storage and Handling 113 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets USP (SR), 100 mg of bupropion hydrochloride, USP are white to off-white, round, bi-convex, film-coated tablets debossed with "WPI" over "858" on one side in: Unit dose packages of 100 (10 x 10) NDC 68084-697-01 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 "839" on one side in: Unit dose packages of 30 (5 x 6) NDC 68084-708-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

📋 Description 160 words ▾

11 DESCRIPTION Bupropion Hydrochloride Extended-release Tablets, USP (SR), an antidepressant of the aminoketone class, is 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 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, and magnesium stearate.

The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol. 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.

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Although bupropion hydrochloride extended-release tablets (SR) are not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN ® which is approved for this use. 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.

Instruct patients to discontinue bupropion and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ]. Severe 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. Seizure Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (SR) 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. As the dose is increased during initial titration to doses above 150 mg/day, instruct patients to take bupropion hydrochloride extended-release tablets (SR) in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.

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) ]. Bupropion-Containing Products Educate patients that bupropion hydrochloride extended-release tablets (SR) contains the same active ingredient (bupropion hydrochloride) found in ZYBAN ® , which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (SR) should not be used in combination with ZYBAN ® or any other medications that contain bupropion (such as WELLBUTRIN ® , the immediate-release formulation and WELLBUTRIN XL ® or FORFIVO XL ® , the extended-release formulations, and APLENZIN ® , the extended-release formulation of bupropion hydrobromide).

In addition,…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dispense with Medication Guide. To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621. 8269701/1125 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 suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (SR)?” Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions 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, depression and other serious mental illnesses, and suicidal thoughts or actions? Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions.

Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.

It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects.

Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes.

Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if bupropion hydrochloride extended-release tablets (SR) are safe and effective in children under the age of 18.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is on…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

akathisia: A feeling of inner restlessness and an urgent need to keep moving, making it hard to sit still.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arthralgia: Joint pain.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bioequivalence: A measure showing two versions of a medicine deliver the same amount of drug into the body at the same rate.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

food effect: A change in how much or how fast a medicine is absorbed when it is taken with food.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

postpartum: The period of time right after a woman gives birth.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

relapse: The return of a cancer after a period of improvement or disappearance.

remission: A period when the signs and symptoms of cancer are reduced or have disappeared.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory failure: A serious condition in which the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suicidality: A general term covering both thoughts about ending one's own life and actions taken toward it.

systemic circulation: The main bloodstream that carries a medicine throughout the whole body.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 68084-0699-01 · American 68084-0709-01 · American →

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.

BuPROPion Hydrochloride 150 mg Tablet, Film Coated, Extended Release

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8 USE IN SPECIFIC POPULATIONS

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