Quick answers
- What is Bupropion used for?
- The FDA-approved label (Wellbutrin SR, GlaxoSmithKline LLC, November 5, 2025) says: “WELLBUTRIN SR (bupropion hydrochloride) is 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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bupropion have a boxed warning?
- Yes. The FDA label for Wellbutrin SR has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bupropion?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bupropion been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started September 15, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bupropion?
- 68 companies list prescription products of Bupropion in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.
What Bupropion is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
WELLBUTRIN SR (bupropion hydrochloride) is 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 […]. …
— FDA label: Wellbutrin SR, GlaxoSmithKline LLC, effective November 5, 2025. Read the full label on DailyMed →
The FDA has 226 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS
. Read it on the full label →
222 of 226 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release · Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 344 in the FDA NDC Directory |
| Brand names | Wellbutrin SR, Aplenzin, Wellbutrin XL, Forfivo XL |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bupropion hydrochloride 100 mg tablet | Generic | $0.1159 per tablet |
| bupropion hydrochloride 100 mg tablet, extended release | Generic | $0.0704 per tablet |
| bupropion hydrochloride 100 mg tablet, film coated | Generic | $0.1159 per tablet |
| bupropion hydrochloride 100 mg tablet, film coated | Brand: Wellbutrin SR | $7.07 per tablet |
| bupropion hydrochloride 100 mg tablet, film coated, extended release | Generic | $0.0704 per tablet |
| bupropion hydrochloride 150 mg tablet | Generic | $0.0782 per tablet |
| bupropion hydrochloride 150 mg tablet, extended release | Generic | $0.0782–$0.2661 per tablet 40 packages, lowest to highest |
| bupropion hydrochloride 150 mg tablet, film coated | Brand: Wellbutrin SR | $7.52 per tablet |
| bupropion hydrochloride 150 mg tablet, film coated, extended release | Generic | $0.0782–$0.2661 per tablet 27 packages, lowest to highest |
| bupropion hydrochloride 200 mg tablet, extended release | Generic | $0.1036 per tablet |
| bupropion hydrochloride 200 mg tablet, film coated | Brand: Wellbutrin SR | $13.99 per tablet |
| bupropion hydrochloride 200 mg tablet, film coated, extended release | Generic | $0.1036 per tablet |
| bupropion hydrochloride 300 mg tablet | Generic | $0.0982 per tablet |
| bupropion hydrochloride 300 mg tablet, extended release | Generic | $0.0982 per tablet |
| bupropion hydrochloride 300 mg tablet, film coated, extended release | Generic | $0.0982 per tablet |
| bupropion hydrochloride 450 mg tablet, extended release | Generic | $8.10 per tablet |
| bupropion hydrochloride 450 mg tablet, film coated, extended release | Generic | $8.10 per tablet |
| bupropion hydrochloride 75 mg tablet | Generic | $0.0953 per tablet |
| bupropion hydrochloride 75 mg tablet, film coated | Generic | $0.0953 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack38 products
- A-S Medication Solutions27 products
- Proficient Rx LP21 products
- Remedyrepack Inc.20 products
- Epic Pharma, LLC11 products
- Coupler LLC11 products
- Preferred Pharmaceuticals Inc.10 products
- PD-Rx Pharmaceuticals, Inc.9 products
- Cipla USA Inc.9 products
- Aphena Pharma Solutions - Tennessee, LLC8 products
- NuCare Pharmaceuticals, Inc.8 products
- Major Pharmaceuticals8 products
- Dr.Reddys Laboratories Inc8 products
- Aurobindo Pharma Limited7 products
- Direct_Rx6 products
- Actavis Pharma, Inc.6 products
- NCS HealthCare of KY, LLC dba Vangard Labs6 products
- BluePoint Laboratories6 products
- American Health Packaging6 products
- Northwind Health Company, LLC6 products
- ScieGen Pharmaceuticals, Inc.6 products
- Radha Pharmaceuticals, Inc.5 products
- Camber Pharmaceuticals, Inc.5 products
- Slate Run Pharmaceuticals, LLC5 products
- Granules Pharmaceuticals Inc.5 products
- Bausch Health US, LLC5 products
- AvPAK4 products
- Chartwell RX, LLC4 products
- Macleods Pharmaceuticals Limited3 products
- Solco Healthcare US, LLC3 products
- GlaxoSmithKline LLC3 products
- Cardinal Health 107, LLC3 products
- Advanced Rx of Tennessee, LLC3 products
- Oceanside Pharmaceuticals3 products
- Exelan Pharmaceuticals Inc.2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Alembic Pharmaceuticals Limited2 products
- Zydus Lifesciences Limited2 products
- Oryza Pharmaceuticals Inc.2 products
- Accord Healthcare Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Apotex Corp.2 products
- Upsher-Smith Laboratories, LLC2 products
- Lannett Company, Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Amici Pharma, Inc.2 products
- Vitruvias Therapeutics2 products
- Cadila Pharmaceuticals Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Modavar Pharmaceuticals LLC2 products
- Mullan Pharmaceutical Inc.2 products
- Asclemed USA, Inc.2 products
- Hawaii Repack, Inc.1 product
- QPharma, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Lifestar Pharma LLC1 product
- NuCare Pharmacueticals, Inc.1 product
- Quality Care Products, LLC1 product
- Unit Dose Solutions, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- DirectRx1 product
- Dr. Reddy's Laboratories Inc.1 product
- DriectRx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020358 WELLBUTRIN SR | Glaxosmithkline | October 4, 1996 | 59, latest November 5, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
| NDA021515 WELLBUTRIN XL | Bausch | August 28, 2003 | 27, latest November 5, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
| NDA022108 APLENZIN | Bausch | April 23, 2008 | 14, latest November 5, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
| NDA022497 FORFIVO XL | Twi Pharms | November 10, 2011 | 6, latest November 5, 2025 2025: Labeling · 2024: Labeling · 2019: Labeling |
Generic approvals (40)
- ANDA075584Pharmazone · February 7, 2000
- ANDA075491Aurobindo Pharma USA · April 17, 2000
- ANDA075932Epic Pharma LLC · November 25, 2003
- ANDA076711Impax Labs · December 3, 2004
- ANDA076143Apotex · January 17, 2006
- ANDA077415Impax Labs · December 15, 2006
- ANDA077715Actavis Labs Fl Inc · June 13, 2007
- ANDA077285Watson Labs Inc · August 15, 2008
- ANDA079094Actavis Labs Fl Inc · March 24, 2009
- ANDA079095Actavis Labs Fl Inc · March 24, 2009
- ANDA078866Sun Pharm · April 6, 2010
- ANDA090325Aurobindo Pharma USA · April 8, 2010
- ANDA201567Zydus Pharms · January 17, 2014
- ANDA200695Sun Pharm · December 18, 2014
- ANDA202304Prinston Inc · May 26, 2015
- ANDA206674Invagen Pharms · February 9, 2016
- ANDA205794Sciegen Pharms · March 1, 2016
- ANDA206122Sciegen Pharms · August 17, 2016
- ANDA206975Heritage Pharma · August 19, 2016
- ANDA206556Invagen Pharms · August 26, 2016
- ANDA090693Lupin · April 6, 2017
- ANDA207479Sciegen Pharms · April 12, 2017
- ANDA207224Anbison Lab · June 30, 2017
- ANDA208652Sinotherapeutics Inc · August 21, 2017
- ANDA207389Invagen Pharms · September 18, 2017
- ANDA210081Twi Pharms · November 3, 2017
- ANDA203013Alembic · June 8, 2018
- ANDA210015Yichang Humanwell · June 14, 2018
- ANDA211347Yichang Humanwell · October 16, 2018
- ANDA210497Accord Hlthcare · October 31, 2018
- ANDA211020Graviti Pharms · January 28, 2019
- ANDA211200Zhejiang Jutai Pharm · September 5, 2019
- ANDA208606Cadila Pharms Ltd · January 16, 2020
- ANDA215568Granules · February 2, 2022
- ANDA216766Yichang Humanwell · January 9, 2023
- ANDA216800Annora Pharma · May 31, 2023
- ANDA218385Granules · October 17, 2024
- ANDA217898Annora Pharma · October 1, 2025
- ANDA218567Macleods Pharms · June 23, 2026
- ANDA216051Aurobindo Pharma Ltd · July 21, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 15, 2025 · Class II · Ongoing · D-0037-2026
Failed Tablet/Capsule Specifications
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Graviti Pharmaceuticals Private Limited
-
June 24, 2024 · Class II · Ongoing · D-0590-2024
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01. — Amerisource Health Services LLC
-
December 29, 2023 · Class II · Ongoing · D-0222-2024
Presence of Foreign Tablets/Capsules
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Tela — Rising Pharma Holding, Inc.
-
December 27, 2022 · Class II · Terminated · D-0328-2023
Failed Impurities/Degradation Specifications
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11 — Amerisource Health Services LLC
-
March 15, 2021 · Class II · Terminated · D-0489-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 — Cardinal Health Inc.
-
September 6, 2018 · Class III · Terminated · D-1212-2018
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68 — InvaGen Pharmaceuticals, Inc.
-
March 15, 2018 · Class III · Terminated · D-0618-2018
Failed Dissolution Specifications; during stability testing
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, — InvaGen Pharmaceuticals, Inc.
-
March 15, 2018 · Class III · Terminated · D-0619-2018
Failed Dissolution Specifications; during stability testing
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Su — InvaGen Pharmaceuticals, Inc.
-
November 2, 2016 · Class III · Terminated · D-0207-2017
Failed Dissolution Specifications; 6 month time point
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distrib — Zydus Pharmaceuticals USA Inc
-
August 3, 2016 · Class III · Terminated · D-0149-2017
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, — Zydus Pharmaceuticals USA Inc
-
November 15, 2013 · Class III · Terminated · D-1043-2014
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laborato — Actavis Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Wellbutrin SR, GlaxoSmithKline LLC, effective November 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →