Bupropion Hydrochloride
- Product NDC
- 0904-7214
- 11-digit product format
- 009047214
- Labeler code
- 0904
- Product ID
- 0904-7214_088173b7-a948-41aa-bf26-7ca117a2ac93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA211347
- Marketing category
- ANDA
- Marketing start
- 2022-07-07
- 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 | 0904-7214 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0904-7214 | 0904-7214-61 | D | Discontinued by firm | 2026-08-11 |
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 | 0904-7214-61 | 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 | 0904-7214-61 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211347-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | |
| A211347-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | |
| A211347-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211347-001 | AB1 |
| A211347-002 | AB1 |
| A211347-003 | AB1 |
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 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A211347-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2018-10-16 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211347-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211347-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211347-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211347-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211347-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211347-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211347-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211347-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211347-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211347-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211347-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211347-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211347-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211347-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211347-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A211347-001 | AB1 | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7214-61 | EA - Each | 0904-7214 | 116b361f-bd56-4c3e-a34e-164317ee6afa | 1 | 2022-09-12 |
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 SR | BUPROPION HYDROCHLORIDE | Epic Pharma, LLC | f8ad76a2-9f75-4660-973d-34402f314e9c | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Northwind Health Company, LLC | f2b3939b-a410-6354-e053-2995a90ababb | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 500fc18d-93b4-47d5-a3f7-3f68822d83e8 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 634bc654-be95-4fea-b308-eed53269a112 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 0574b84d-075f-410f-a8eb-86901e307ea2 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 2024-06-16 | Boxed warning, Warnings, Adverse reactions | 211347 ANDA211347 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-7214-61 | 00904721461 | 100 BLISTER PACK in 1 CARTON (0904-7214-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2022-07-07 | 0000-00-00 | No | No | Current |