BUPROPION HYDROCHLORIDE
- Product NDC
- 70518-2051
- 11-digit product format
- 705182051
- Labeler code
- 70518
- Product ID
- 70518-2051_e9acce8a-f7d7-6258-e053-2a95a90a7f70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPROPION HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210497
- Marketing category
- ANDA
- Marketing start
- 2019-04-30
- 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 | 70518-2051 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-2051 | 70518-2051-0 | D | Discontinued by firm | 2026-08-03 |
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 | 70518-2051-0 | 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 | 70518-2051-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-2051-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-2051-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-2051-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-2051-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-2051-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-2051-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2051-0 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210497-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | |
| A210497-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210497-001 | AB3 |
| A210497-002 | AB3 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210497-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210497-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2018-10-31 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210497-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210497-002 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210497-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210497-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210497-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210497-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210497-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210497-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210497-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210497-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210497-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210497-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210497-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210497-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210497-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210497-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210497-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210497-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210497-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210497-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210497-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210497-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210497-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210497-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210497-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210497-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210497-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210497-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210497-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210497-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210497-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210497-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210497-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210497-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210497-001 | AB3 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210497-002 | AB3 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210497-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210497-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210497-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210497-002 | AB3 | 1 | 782e0a99824c… |
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 | REMEDYREPACK INC. | 080853c0-fcab-4645-9ddc-4946e895ac5f | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 82bcdd72-9146-4c8d-a8aa-f92015864605 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 42e228a2-25b3-44a6-8da7-6616ca44ac7f | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ae3bcdf7-d7f3-4f07-8113-af08af20a0d4 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Accord Healthcare Inc. | 34686e9d-c106-4276-8b47-7460cca8860e | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 5dec4414-5595-46c9-ada9-3fbe98152040 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | DIRECT RX | 96d87edc-d12b-44b2-e053-2995a90a4e63 | 2025-01-22 | Warnings, Adverse reactions | 210497 ANDA210497 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8af7829-8b61-6785-e053-6294a90af052 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 29a6c6e3-f30f-6541-e063-6394a90ae11d | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Quality Care Products, LLC | a225dbbb-86f0-4547-a1c8-68eb64cd6892 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | BluePoint Laboratories | 5ccec958-998d-43a1-86fb-eb2b5e697b77 | 2024-11-30 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 7c46d95a-26f6-4364-8197-9e564e3405f2 | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | a18b5460-fcbb-42dd-8b87-197d11a08928 | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 77b78d35-40f5-4713-8468-aa09a6c2925d | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 5d40e301-7e06-4ecd-b7c6-3d7ac6a134d2 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 42201f4a-8856-4499-8bc3-d18612b1ec34 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 210497 ANDA210497 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-2051-0 | 70518205100 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2051-0) | 2019-04-30 | 0000-00-00 | No | No | Current |