Home › NDC Lookup › Ingredients › Bupropion › 68382-0353-16

bupropion 150 mg Tablet, Extended Release, 90-count

by Zydus Pharmaceuticals USA Inc. · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-16)

NDC 68382-0353-16

🏷️ FDA NDC (as labeled) 68382-353-16 billing pads the product segment with a zero

This package

Contains90-count Cost per ea$0.0787 NADAC Per package$7.08 / 90 tablets Pack sizes4 compare ↓

Also priced by: Medicaid pays $0.4162/unit · Part D plans $0.3192/unit — full pricing hub ↓

Also comes in: 30 tablets 68382-0353-06 500 tablets 68382-0353-05 1000 tablets 68382-0353-10

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

🆔 Identity & classification

FDA NDC (as labeled) 68382-353-16

Product NDC 68382-353

11-digit billing NDC 68382035316

NCPDP billing unit EA — each (per item)

RxCUI 993541, 993557

UNII ZG7E5POY8O

Application # ANDA201567

SPL Set ID 8d937ca3-3351-40f1-8192-348ba0c68162

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 2018-08-02

Route ORAL

Dosage form TABLET, EXTENDED RELEASE

Substance BUPROPION HYDROCHLORIDE

GPI-14 58300040107520

GPI class buPROPion HCl ER (XL)

GCN Seq No 053006

GCN 20317

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 XL 150 MG TABLET

FDB brand name Bupropion Xl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB3 · RLD · RS

Why two NDCs? The FDA registers this code as 68382-353-16 — 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 → 68382-0353-16. 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

LabelerZydus Pharmaceuticals USA Inc.

Application holderZYDUS PHARMACEUTICALS USA INC

FDA applicationANDA201567 (ANDA)

Labeler code68382

First marketedAug 2018

Product typeHuman Prescription Drug

Portfolio451 products on file

🔎 All NDCs from Zydus Pharmaceuticals USA Inc.

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 XL 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

Some supplements/herbs that may interact with Bupropion — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Bupropion (46 interactions) — ranked by severity →

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 Yellow

ShapeRound

Imprint353

Size8 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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
UNII 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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 1CS02G8656
Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

14 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	$0.079	$7.08 / 90 tablets
Medicaid paysCMS SDUD · 12 mo	$0.4162	$37.46 / 90 tablets
Medicare drug plans payPart D · Q2 2026	$0.3192	$28.73 / 90 tablets

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

▼ Down 44% 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 2%
Bupropion Hydrochloride (XL) 150 mg 24979-0101-02	Upsher-Smith	500 tablets	$0.078	—	Discontinued	save 1%
Bupropion hydrochloride 150 mg 63304-0723-05	Sun	500 tablets	$0.079	—	Discontinued	+0%
Bupropion Hydrochloride XL 150 mg 00591-3331-05	Actavis	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 00904-7505-04	Major	1 tablet	$0.079	AB3	Availability likely	—
bupropion hydrochloride 150 mg 16571-0862-03	Rising	30 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride 150 mg 16729-0443-10	Accord	30 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride 150 mg 31722-0487-05	Camber	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 42806-0348-05	Epic	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 42806-0414-05	Epic	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride (XL) 150 mg 50228-0144-05	ScieGen	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride 150 mg 50268-0133-13	AvPAK	1 tablet	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride 150 mg 60687-0782-01	American	1 tablet	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride (Xl) 150 mg 62135-0875-30	Chartwell	30 tablets	$0.079	AB3	Availability likely	—
Bupropion hydrochloride 150 mg 68001-0613-03	BluePoint	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 68180-0319-02	Lupin	500 tablets	$0.079	AB3	Availability likely	—
bupropion 150 mgthis 68382-0353-16	Zydus	90 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride 150 mg 69097-0071-12	Cipla	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 69367-0288-05	Westminster	500 tablets	$0.079	AB3	Discontinued	—
Bupropion hydrochloride 150 mg 70010-0784-03	Granules	30 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 82009-0051-05	Quallent	500 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride (XL) 150 mg 83301-0024-01	Mullan	30 tablets	$0.079	AB3	Availability likely	—
Bupropion Hydrochloride XL 150 mg 70436-0010-02	Slate	500 tablets	$0.079	AB3	Availability likely	+0%
Bupropion Hydrochloride (XL) 150 mg 43598-0655-05	Dr	500 tablets	$0.108	AB3	FDA listed	+37%
Bupropion hydrochloride (XL) 150 mg 00527-2415-32	Lannett	30 tablets	$0.119	AB3	FDA listed	+52%
Bupropion Hydrochloride (XL) 150 mg 69097-0875-02	CIPLA	30 tablets	$0.119	—	FDA listed	+52%
Bupropion Hydrochloride 150 mg 00115-6811-02	Amneal	500 tablets	—	—	FDA listed	—
Wellbutrin Xl 150 mg 00187-0730-07	Bausch	7 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 00615-8504-05	NCS	15 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 47335-0954-13	Sun	500 tablets	—	—	FDA listed	—
Bupropion Hydrochloride XL 150 mg 50090-4049-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-4747-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-5163-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-6789-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 50090-7109-00	A-S	90 tablets	—	—	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 50090-7110-00	A-S	90 tablets	—	—	FDA listed	—
Bupropion Hydrochloride XL 150 mg 50090-7112-00	A-S	90 tablets	—	AB3	Discontinued	—
Bupropion Hydrochloride XL 150 mg 50090-7113-00	A-S	90 tablets	—	AB3	Discontinued	—
Bupropion Hydrochloride 150 mg 50090-7711-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 50090-7712-00	A-S	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 51655-0098-26	Northwind	90 tablets	—	AB3	FDA listed	—
Bupropion HCL ER (XL) 150 mg 61919-0558-60	Direct_Rx	60 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 63187-0713-30	Proficient	30 tablets	—	—	FDA listed	—
Bupropion Hydrochloride XL 150 mg 63187-0766-30	Proficient	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 63629-8474-01	Bryant	30 tablets	—	AB3	FDA listed	—
bupropion 150 mg 65841-0836-05	Zydus	500 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 67046-0699-03	Coupler	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 68071-3559-09	NuCare	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 68071-3594-03	NuCare	30 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 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 69680-0157-30	Vitruvias	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 70518-2022-02	REMEDYREPACK	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 70518-2458-00	REMEDYREPACK	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 70518-3963-00	REMEDYREPACK	30 tablets	—	AB3	Discontinued	—
Bupropion hydrochloride 150 mg 70518-4189-00	REMEDYREPACK	30 tablets	—	AB3	FDA listed	—
Bupropion hydrochloride 150 mg 70518-4448-00	REMEDYREPACK	30 tablets	—	AB3	FDA listed	—
bupropion hydrochloride 150 mg 70518-4674-00	REMEDYREPACK	30 tablets	—	AB3	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 150 mg 71335-1044-01	Bryant	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 71335-2378-01	Bryant	30 tablets	—	AB3	FDA listed	—
Bupropion hydrochloride 150 mg 71335-2469-01	Bryant	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 72162-1526-05	Bryant	500 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 72189-0134-30	DIRECT	30 tablets	—	AB3	FDA listed	—
buPropion Hydrochloride XL 150 mg 72516-0035-03	Oryza	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 72789-0377-90	PD-Rx	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 76282-0480-05	Exelan	500 tablets	—	—	FDA listed	—
Bupropion Hydrochloride XL 150 mg 76420-0923-01	Asclemed	100 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 77771-0144-05	RADHA	500 tablets	—	AB3	FDA listed	—
Bupropion hydrochloride 150 mg 80425-0300-01	Advanced	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride 150 mg 80425-0461-01	Advanced	30 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride XL 150 mg 82804-0080-30	Proficient	30 tablets	—	AB3	FDA listed	—
Bupropion hydrochloride 150 mg 82804-0296-90	Proficient	90 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 82868-0097-96	Northwind	180 tablets	—	AB3	FDA listed	—
Bupropion Hydrochloride (XL) 150 mg 83008-0082-30	Quality	30 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

🏛️

2018

On the market since

Aug 2018

📍

2026

Currently FDA-listed

8 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 68382-0353-16, 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

410

Units reimbursed last 4 qtrs

14.7K

Gross reimbursed last 4 qtrs

$6.1K

Avg / prescription

$14.91

Avg / unit

$0.4162

Latest quarter Q4 2025

79Rx

Medicaid pays / ea

$0.4162

gross reimbursed

NADAC / ea

$0.0787

acquisition cost

Spread

+$0.3375

+429% 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 ⓘ

78% FFS 22% MCO

Fee-for-service · 318 Rx Managed care · 92 Rx

State Medicaid map

Units reimbursed · per 100k residents

10.666.3

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 Montana 66.3 /100k

2 Louisiana 63.0 /100k

3 California 20.0 /100k

4 New York 13.3 /100k

5 Missouri 10.6 /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.

💊 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.

90 tablets this page68382-0353-16 410 Rx · $6,115

500 tablets68382-0353-05 254 Rx · $4,507

30 tablets68382-0353-06 68 Rx · $638

1000 tablets68382-0353-10 No Medicaid data

Drug total (last 4 qtrs): 732 Rx · 27,625 units · $11,260 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 — the ingredient across all brands.

Top reported reactions

Nausea11,909

Fatigue10,076

Headache10,053

Depression8,639

Dizziness7,786

Anxiety7,785

Pain6,854

Reporter sex

Serious outcomes

Hospitalization34,010

Death13,503

Life-threatening4,473

Disabling3,613

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	Per unit	Per pack	Marketing start	Status
68382-0353-05	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-05)	$0.0787 / ea	$39.36	2018-08-02	Active
68382-0353-06	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-06)	$0.0787 / ea	$2.36	2018-08-02	Active
68382-0353-10	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-10)	—	—	2018-08-02	Active
68382-0353-16 You're viewing this	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-16)	$0.0787 / ea	$7.08	2018-08-02	Active

You're viewing one of 4 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0787 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 56% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 68382-0353-16?

NDC 68382-0353-16 is a 90-count package — 90 tablet, extended release in 1 bottle.

What is the difference between NDC 68382-0353-16 and NDC 68382-0353-06?

Both are bupropion 150 mg Tablet, Extended Release — the drug itself is identical. NDC 68382-0353-16 is the 90-count package, while NDC 68382-0353-06 is the 30 tablets package.

What NDC number is used to bill for this package of bupropion 150 mg Tablet, Extended Release?

Bill NDC 68382-0353-16 — the 11-digit billing format is 68382035316. 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.

📄 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 146 words ▾

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 ) 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 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 )] .

🎯 Indications and Usage 215 words ▾

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 )

1.1Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4 week controlled inpatient trials and one 6 week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8 week study of acute treatment [see Clinical Studies ( 14.1 ) ] .

1.2Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies ( 14.2 )] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION General Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Periodically reassess the dose and need for maintenance treatment. ( 2.2 ) Major Depressive Disorder Starting dose: 150 mg once daily.

Usual target dose: 300 mg once daily ( 2.2 ) After 4 days, may increase the dose to 300 mg once daily. ( 2.2 ) Seasonal Affective Disorder Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.3 ) Starting dose: 150 mg once daily.

Usual target dose: 300 mg once daily. ( 2.3 ) After one week, may increase the dose to 300 mg once daily. ( 2.3 ) Continue treatment through the winter season.

( 2.3 ) Hepatic Impairmen t Moderate to severe hepatic impairment: 150 mg every other day ( 2.6 ) 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 of dosing. ( 2.7 , 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 (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (XL) should be administered in the morning and may be taken with or without food.

2.2Dosage for Major Depressive Disorder (MDD) The recommended starting dose for MDD is 150 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode.

It is unknown whether the bupropion hydrochloride extended-release tablets (XL) dose 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.

2.3Dosage for Seasonal Affective Disorder (SAD) The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion hydrochloride extended-release were not assessed in the SAD trials.

For the prevention of seasonal MDD episodes associated with SAD, initiate bupropion hydrochloride extended-release tablets (XL) in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue bupropion hydrochloride extended-release tablets (XL) in early spring.

For patients treated with 300 mg per day, decrease the dose to 150 mg once daily before discontinuing bupropion hydrochloride extended-release tablets (XL). Individualize the timing of initiation, and duration of treatment should be individualized, based on the patient's historical pattern of seasonal MDD episodes.

2.4Switching Patients from Bupropion Hydrochloride Tablets or from Bupropion Hydrochloride Sustained-Release Tablets When switching patients from bupropion hydrochloride tablets to bupropion hydrochloride extended-release tablets (XL) or from bupropion hydrochloride sustained-release tablets to bupropion hydrochloride extended-release tablets (XL), give the same total daily dose when possible.

2.5To Discontinue Bupropion Hydrochloride Extended-Release Tablets (XL), Taper the Dose When discontinuing treatment in patients treated with bupropion hydrochloride extended-release tablets (XL) 300 mg once daily, decrease the dose to 150 mg once daily prior to discontinuation.

2.6Dosage Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 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 ) and Clinical Pharmacology ( 1…

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 150 mg, 300 mg ( 3 ) Bupropion hydrochloride extended-release tablets USP (XL), 150 mg are creamy-white to pale-yellow, round, biconvex, beveled-edge coated-tablets imprinted with '353' in black ink on one side and plain on other side. Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg are creamy-white to pale-yellow, round, biconvex, coated-tablets imprinted with '354' in black ink on one side and plain on other side.

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS 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 (XL) or within 14 days of stopping treatment with bupropion hydrochloride extended-release tablets (XL). Do not use bupropion hydrochloride extended-release tablets (XL) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-release tablets (XL) 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 (XL) ( 4 , 5.8 ) Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) is 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 bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions ( 5.3 )].

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ) and Drug Interactions ( 7.3 )] . The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs.

The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [ see Dosage and Administration ( 2.9 ), Warnings and Precautions ( 5.4 ) and Drug Interactions ( 7.6 ) ] . Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL).

Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions ( 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 hydrochloride extended-release tablets (XL)for the occurrence of such symptoms and instruct them to discontinue bupropion hydrochloride extended-release tablets (XL) and contact a healthcare provider if they experience such adverse events.

( 5.2 ) Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 450 mg and gradually increasing the dose. Discontinue if seizure occurs.

( 4 , 5.3 , 7.3 ) Hypertension: Bupropion hydrochloride extended-release tablets (XL) 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 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 major depressive disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to 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 4400 patients. 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 patients.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients 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 1000 patients 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 Pe…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions are (incidence ≥ 5%; ≥ 2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings 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 events [see Warnings and Precautions ( 5.6 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )]

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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride. Adverse reactions that occurred in at least 5% of patients treated with bupropion hydrochloride sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.

300 mg/day of bupropion hydrochloride sustained-release: anorexia, dry mouth, rash, sweating, tinnitus, and tremor. 400 mg/day of bupropion hydrochloride sustained-release: abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Bupropion hydrochloride extended-release tablets (XL) have been demonstrated to have similar bioavailability both to the immediate-release and sustained-release formulations of bupropion.

The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride. Major Depressive Disorder Adverse Reactions Leading to Discontinuation of Treatment with Bupropion hydrochloride Immediate-Release, Bupropion hydrochloride Sustained-Release, and Bupropion hydrochloride Extended-Release in Major Depressive Disorder Trials In placebo-controlled clinical trials with bupropion hydrochloride sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of 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 Discontinuation Due to Adverse Reactions in Placebo-Controlled Trials in MDD Adverse Reaction Term Placebo (n=385) Bupropion Hydrochloride Sustained-Release 300 mg/day (n=376) Bupropion Hydrochloride Sustained-Release 400 mg/day (n=114) Rash 0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0% 1.8% In clinical trials with bupropion hydrochloride immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction.

Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances. Adverse Reactions Occurring at an Incidence of > 1% in Patients Treated with Bupropion hydrochloride Immediate-Release or Bupropion hydrochloride Sustained-Release in MDD Table 3 summarizes the adverse reactions th…

🔄 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 exposure, 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 ) Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (XL) with caution. ( 5.3 , 7.3 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL).

( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL). ( 7.6 ) Drug-laboratory test interactions: Bupropion hydrochloride extended-release tablets (XL) can cause false-positive urine test results for amphetamines. ( 7.7 )

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

Based on clinical response, dosage adjustment of bupropion hydrochloride extended-release tablets (XL) 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 (XL) may be necessary when coadministered with ritonavir, lopinavir, or efavirenz but should not exceed the maximum recommended dose [see Clinical Pharmacology ( 12.3 ) ] .

Carbamazepine, Phenobarbital, Phenytoin: While not systemically studied, these drugs may induce 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 (XL) 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 (XL) 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, and thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, and flecainide).

When used concomitantly with bupropion hydrochloride extended-release tablets (XL), 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. Patients treated concomitantly with bupropion hydrochloride extended-…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to 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/clinical-and-researchprograms/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 (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 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 are unknown for the indicated population. All pregnancies have a background rate of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and 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 has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 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 left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted odds ratio (OR) = 2.6; 95% CI 1.2, 5.7), and the Slone Epidemiology…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. When considering the use of bupropion hydrochloride extended-release tablets (XL) in a child or adolescent, balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions ( 5.1 )] .

🧓 Geriatric Use 187 words ▾

8.5Geriatric Use Of the approximately 6000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥ 65 years old and 47 were ≥ 75 years old. In addition, several hundred patients ≥ 65 years of age participated in clinical trials using the immediate-release formulation of bupropion hydrochloride (depression studies). 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 ) , and Clinical Pharmacology ( 12.3 ) ] .

🆘 Overdosage 172 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 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. Following chronic dosing, the mean steady-state plasma concentration of bupropion was reached within 8 days.

The mean elimination half-life (±SD) of bupropion is 21 (±9) hours. In a study comparing 14 day dosing with bupropion hydrochloride extended-release tablets (XL), 300 mg once-daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the three metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion). Additionally, in a study comparing 14 day dosing with bupropion hydrochloride extended-release tablets (XL) 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the three metabolites.

Absorption Following single oral administration of bupropion hydrochloride extended-release tablets (XL) to healthy volunteers, the median time to peak plasma concentrations for bupropion was approximately 5 hours. The presence of food did not affect the peak concentration or area under the curve of bupropion. 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 of 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 as high or higher than those of bupropion. At steady state, peak plasma concentration of hydroxybupropion occurred approximately 7 hours after administration of bupropion hydrochloride extended-release tablets (XL), and it was approximately 7 times the peak level of the parent drug.

The elimination half-life of hydroxybupropion is approximately 20 (±5) hours, and its AUC at steady state is about 13 times that of bupropion. The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of hydroxybupropion. However, the elimination half-lives of erythrohydrobupropion and threohydrobupropion are longer, approximately 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs were 1.4 and 7 times that of bupropion, respectively.

Bupropion and…

🧬 Mechanism of Action 58 words ▾

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg are creamy-white to pale-yellow, round, biconvex, beveled-edge coated-tablets imprinted with '353' in black ink on one side and plain on other side and are supplied as follows: NDC 68382-353-06 in bottle of 30 tablets with child-resistant closure NDC 68382-353-16 in bottle of 90 tablets with child-resistant closure NDC 68382-353-05 in bottle of 500 tablets NDC 68382-353-10 in bottle of 1000 tablets Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg are creamy-white to pale-yellow, round, biconvex, coated-tablets imprinted with '354' in black ink on one side and plain on other side and are supplied as follows: NDC 68382-354-06 in bottle of 30 tablets with child-resistant closure NDC 68382-354-16 in bottle of 90 tablets with child-resistant closure NDC 68382-354-05 in bottle of 500 tablets NDC 68382-354-10 in bottle of 1000 tablets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP. Bupropion Hydrochloride Extended-release Tablets USP (XL) may have an odor.

📋 Description 202 words ▾

11 DESCRIPTION Bupropion hydrochloride extended-release tablets, USP (XL) is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-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, USP powder is white, crystalline, and highly soluble in water, in

0.1N hydrochloric acid, and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Each bupropion hydrochloride extended-release tablets, USP (XL) intended for oral administration contains 150 mg or 300 mg of bupropion hydrochloride.

In addition, each tablet contains the following inactive ingredients: ethyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol, povidone, silicon dioxide, triethyl citrate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, butyl alcohol, iron oxide black, isopropyl alcohol, propylene glycol and shellac. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.

The Product meets USP Dissolution Test 26. Bupropion hydrochloride extended-release tablets, USP (XL)

💬 Information for Patients ~2 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 health 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 (XL) 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 hydrochloride extended-release tablets (XL) and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Severe Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (XL) if they have a severe allergic reaction. Seizure Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (XL) if they experience a seizure while on treatment.

Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol. Angle - Closure Glaucoma Patients should be advised that taking bupropion hydrochloride extended-release tablets (XL) 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 (XL) contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as WELLBUTRIN SR, the sustained-release formulation, WELLBUTRIN, the immediate-release formulation, and APLENZIN ® , a bupropion hydrobromide formulation).

In addition, there are a number of generic bupropion hydrochloride products for the immediate, sustained, and extended-release formulations. Potential for Cognitive and Motor Impairment Advise patients that any CNS-active drug like bupropion hydrochloride extended-release tablets…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Bupropion Hydrochloride (bue proe' pee on hye" droe klor' ide) Extended-Release Tablets, USP (XL) 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 (XL)?" 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 (XL) 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 only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to qui…

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.

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.

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.

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.

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.

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.

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.

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

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.

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

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

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.

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 ↗

← 68382-0352-01 · Zydus 68382-0354-05 · Zydus →

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 150 mg Tablet, Extended Release, 90-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

📄 Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class