BUPROPION HYDROCHLORIDE
- Product NDC
- 63187-124
- 11-digit product format
- 631870124
- Labeler code
- 63187
- Product ID
- 63187-124_c10e09c6-2958-4fdd-beba-53c388d3f2e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077284
- Marketing category
- ANDA
- Marketing start
- 2014-01-27
- 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
- 2020-12-31
- 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 | 63187-124 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63187-124 | 63187-124-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63187-124 | 63187-124-90 | D | Discontinued by firm | 2026-08-17 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-124-90 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-124-30 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-124-90 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-124-30 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63187-124-30 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63187-124-90 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077284-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | ||
| A077284-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2006-12-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077284-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077284-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2006-12-14 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077284-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077284-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077284-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077284-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077284-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077284-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077284-001 | AB3 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077284-002 | AB3 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077284-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077284-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077284-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077284-002 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077284-001 | AB3 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077284-002 | AB3 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077284-001 | AB3 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077284-002 | AB3 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077284-001 | AB3 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077284-002 | AB3 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077284-001 | AB3 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077284-002 | AB3 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077284-001 | AB3 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077284-002 | AB3 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077284-001 | AB3 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077284-002 | AB3 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077284-001 | AB3 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077284-002 | AB3 | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A077284-002 | AB3 | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077284-002 | AB3 | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077284-002 | AB3 | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077284-001 | AB3 | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077284-002 | AB3 | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077284-001 | AB3 | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077284-002 | AB3 | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077284-001 | AB3 | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A077284-002 | AB3 | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077284-001 | AB3 | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A077284-002 | AB3 | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077284-001 | AB3 | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077284-002 | AB3 | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077284-001 | AB3 | 1 | f41ea6bd6efb… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-124-30 | EA - Each | 63187-124 | 18445899-bc6a-44cf-a326-746152ba0093 | 1 | 2015-05-05 |
| 63187-124-90 | EA - Each | 63187-124 | c813b123-2377-4461-9026-3a4c5f97bf34 | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-124-30 | 63187012430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-124-30) | 2014-07-01 | 0000-00-00 | No | No | Current |
| 63187-124-90 | 63187012490 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-124-90) | 2014-07-01 | 0000-00-00 | No | No | Current |