Bupropion hydrochloride
- Product NDC
- 67046-1273
- 11-digit product format
- 670461273
- Labeler code
- 67046
- Product ID
- 67046-1273_5604ea96-6036-45b7-e063-6294a90a646e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA216800
- Marketing category
- ANDA
- Marketing start
- 2026-07-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216800-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | |
| A216800-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | |
| A216800-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216800-001 | AB1 |
| A216800-002 | AB1 |
| A216800-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216800-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2023-05-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216800-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216800-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216800-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A216800-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216800-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216800-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216800-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216800-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216800-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216800-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216800-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216800-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216800-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216800-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216800-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216800-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216800-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216800-001 | AB1 | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupropion hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPROPION HYDROCHLORIDE | 150 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ZG7E5POY8O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 993518 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5604eb14-bab4-4f06-e063-6294a90a6920 | Available on FDA.report |
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 HCL ER(SR) | BUPROPION HCL ER(SR) | DriectRx | 50afb442-e7c6-d28c-e063-6294a90a2b7e | 2026-08-31 | Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 6087100f-3ba4-412e-b08d-768d1dcdaf00 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | 0aa86bd6-b37b-45f7-a837-b067e41184e9 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 5604eb14-bab4-4f06-e063-6294a90a6920 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 67046-1273 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 350336bf-57b1-4d2f-bf25-956bb6023c07 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 5c111cf0-0199-4a4d-8138-81579af4c14d | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 4c9a5dc3-bebe-431a-b550-ce46c6c6b01e | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | f69b322b-93ab-407a-bf25-fe13c6896ca6 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 093c4a61-02d9-4b55-b612-569aa25d3f2a | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 1bd2ed35-35c5-464f-bf51-9dd4b42ee59a | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Coupler LLC | 38f52cec-9534-dab8-e063-6294a90a0704 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | c5d55b0c-8b81-476a-994e-1989e2a56255 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | bb63261f-ad18-4885-9ed7-e7dfde33e171 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
| Bupropion hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | a724b3b6-f60e-4b88-8603-8141a32075da | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | 216800 ANDA216800 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 67046-1273-3 | 67046127303 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1273-3) | 2026-07-07 | No | No | Current |