Bupropion hydrochloride
- Product NDC
- 50090-0862
- 11-digit product format
- 500900862
- Labeler code
- 50090
- Product ID
- 50090-0862_199f6d0c-bfe2-44cc-b44b-3c3c9c12faa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078866
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-0862 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 50090-0862 | 50090-0862-0 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 50090-0862 | 50090-0862-1 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 50090-0862 | 50090-0862-2 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 50090-0862 | 50090-0862-3 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0862-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0862-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0862-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0862-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0862-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0862-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0862-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0862-2 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078866-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | ||
| A078866-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | ||
| A078866-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078866-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078866-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078866-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2010-04-06 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A078866-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078866-002 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078866-003 | AB1 | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078866-002 | AB1 | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078866-003 | AB1 | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078866-002 | AB1 | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A078866-003 | AB1 | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078866-001 | AB1 | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A078866-002 | AB1 | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A078866-003 | AB1 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078866-001 | AB1 | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078866-002 | AB1 | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078866-003 | AB1 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078866-001 | AB1 | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078866-002 | AB1 | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078866-003 | AB1 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078866-001 | AB1 | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078866-002 | AB1 | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078866-003 | AB1 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078866-001 | AB1 | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078866-002 | AB1 | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078866-003 | AB1 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078866-001 | AB1 | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078866-002 | AB1 | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078866-003 | AB1 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078866-001 | AB1 | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078866-002 | AB1 | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078866-003 | AB1 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078866-001 | AB1 | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078866-002 | AB1 | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078866-003 | AB1 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078866-001 | AB1 | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A078866-002 | AB1 | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A078866-003 | AB1 | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A078866-001 | AB1 | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A078866-002 | AB1 | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A078866-003 | AB1 | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078866-001 | AB1 | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078866-002 | AB1 | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078866-003 | AB1 | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0862-0 | EA - Each | 50090-0862 | a7a4a743-b896-4a28-81ba-e05c86b4e14d | 1 | 2022-09-12 |
| 50090-0862-1 | EA - Each | 50090-0862 | f0054449-2d9d-46ad-97e7-dd84930d399e | 1 | 2022-09-12 |
| 50090-0862-2 | EA - Each | 50090-0862 | 22742475-2762-4533-a387-e89772511679 | 1 | 2022-09-12 |
| 50090-0862-3 | EA - Each | 50090-0862 | e7d83aa9-d92b-4b71-b300-e4213fd50b9f | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0862 | BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 9 | Legacy NDC | 20231210_fbfb1966-8450-49b4-b329-7812f0f83462.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 29848192-7de3-4c0d-a822-1268dcf128b0 | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | 078866 ANDA078866 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Proficient Rx LP | d4272e3f-78ee-4d80-b911-e840fb14acbe | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 078866 ANDA078866 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-0862-0 | 50090086200 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0862-0) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50090-0862-1 | 50090086201 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0862-1) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50090-0862-2 | 50090086202 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0862-2) | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50090-0862-3 | 50090086203 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0862-3) | 2022-08-15 | 0000-00-00 | No | No | Current |