Bupropion Hydrochloride
- Product NDC
- 64980-201
- 11-digit product format
- 649800201
- Labeler code
- 64980
- Product ID
- 64980-201_74120afa-f695-48b1-9eef-36d58d56b906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA203013
- Marketing category
- ANDA
- Marketing start
- 2018-06-18
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 75 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 | 64980-201 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 64980-201 | 64980-201-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 64980-201 | 64980-201-05 | 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 | 64980-201-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 64980-201-01 | 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 | 64980-201-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 64980-201-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64980-201-05 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64980-201-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64980-201-05 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64980-201-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64980-201-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64980-201-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203013-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | |
| A203013-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203013-001 | AB |
| A203013-002 | AB |
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 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203013-001 | BUPROPION HYDROCHLORIDE | 75MG | TABLET / ORAL | AB | 2018-06-08 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203013-002 | BUPROPION HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-08 | 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 | A203013-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203013-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203013-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203013-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203013-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203013-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203013-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203013-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203013-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203013-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203013-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203013-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203013-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203013-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203013-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203013-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203013-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203013-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203013-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203013-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203013-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203013-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203013-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203013-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203013-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203013-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203013-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A203013-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203013-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203013-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203013-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A203013-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203013-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A203013-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203013-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203013-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203013-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A203013-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203013-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203013-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4eceb285-f3c7-4092-a21a-4c9f3169f20c | Product name | 5 | 20260220 |
| 548ba7fd-fd0c-4a21-b2b0-d01bf93143b8 | Product name | 3 | 20240209 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| b8ee525f-67fb-39fb-91da-7e47ac54581d | Product name | 5 | 20200611 |
| 98e65af1-f5d0-75d5-c930-f8a4ce4c3284 | Product name | 9 | 20190211 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 0916dcfb-331f-89b1-8eac-6f7dc76d82da | Product name | 1 | 20140508 |
| d7fc3d53-5a6c-de82-2808-1780f175f17e | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-201-01 | EA - Each | 64980-201 | b7af96f7-19ac-497d-a8db-4ef5cedbc0d6 | 1 | 2018-11-06 |
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. | 990587bd-4c7d-4a36-8a38-3104648ab3a2 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 203013 ANDA203013 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 81d251aa-a8e8-493e-94ed-12f6fb8902e6 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 203013 ANDA203013 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | b303a0ad-5971-44ab-937c-bcf3ff650358 | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | 203013 ANDA203013 |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Alembic Pharmaceuticals Limited | ef0bb8f2-7710-4236-8b47-57b74c8bca3e | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | 203013 ANDA203013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993691 | buPROPion HCl 75 MG Oral Tablet | PSN | 6a300adb-b1c2-4250-bd15-272b04699edd | 1 |
| 993691 | bupropion hydrochloride 75 MG Oral Tablet | SCD | 6a300adb-b1c2-4250-bd15-272b04699edd | 1 |
| 993691 | bupropion HCl 75 MG Oral Tablet | SY | 6a300adb-b1c2-4250-bd15-272b04699edd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64980-201-01 | 64980020101 | 100 TABLET, FILM COATED in 1 BOTTLE (64980-201-01) | 2018-06-18 | 0000-00-00 | No | No | Current |
| 64980-201-05 | 64980020105 | 500 TABLET, FILM COATED in 1 BOTTLE (64980-201-05) | 2018-06-18 | 0000-00-00 | No | No | Current |