Bupropion Hydrochloride
- Product NDC
- 68788-7863
- Requested package NDC
- 68788-7863-9
- 11-digit product format
- 687887863
- Labeler code
- 68788
- Product ID
- 68788-7863_1ca3b0e4-bdae-408e-8a39-4e43252d6111
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA210081
- Marketing category
- ANDA
- Marketing start
- 2021-02-08
- Marketing end
- 0000-00-00
- Substance
- BUPROPION HYDROCHLORIDE
- Active strength
- 300 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
- 2022-12-31
- 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 package | package | 68788-7863 | 68788-7863-9 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210081-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | ||
| A210081-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 |
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 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | 2017-11-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-002 | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB3 | 2017-11-03 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A210081-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210081-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210081-002 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210081-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210081-002 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210081-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210081-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210081-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210081-002 | AB3 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-001 | AB3 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210081-002 | AB3 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-001 | AB3 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210081-002 | AB3 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-001 | AB3 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210081-002 | AB3 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-001 | AB3 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210081-002 | AB3 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-001 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210081-002 | AB3 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-001 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210081-002 | AB3 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-001 | AB3 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210081-002 | AB3 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-001 | AB3 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210081-002 | AB3 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-001 | AB3 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210081-002 | AB3 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210081-001 | AB3 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210081-002 | AB3 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210081-001 | AB3 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210081-002 | AB3 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210081-001 | AB3 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A210081-002 | AB3 | 1 | 5aa47cf7b7d7… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7863-1 | EA - Each | 68788-7863 | 80410f0a-5d31-43aa-9e5d-2fa2f2595c5e | 1 | 2021-03-02 |
| 68788-7863-3 | EA - Each | 68788-7863 | accb1c52-6ec6-4873-bc1f-32b818fa2d0b | 1 | 2021-03-02 |
| 68788-7863-6 | EA - Each | 68788-7863 | 93f90be0-400a-401d-b197-a0665cc881f8 | 1 | 2021-03-02 |
| 68788-7863-8 | EA - Each | 68788-7863 | 1ab2cb4a-ee19-431c-8768-72e4eca96e10 | 1 | 2021-03-02 |
| 68788-7863-9 | EA - Each | 68788-7863 | c2c76878-f13c-4905-ba3d-cbfe30423c48 | 1 | 2021-03-02 |
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 (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 9d5360f5-f747-4baf-8e6c-ddca1a9c871a | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 64be3113-837a-48f3-9f9e-400529c9ee94 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 62d0dcb5-c70b-4884-9755-740f62a8b31a | 2024-03-14 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 8ae81b03-b447-4a3f-8ed9-ebf75ee52b49 | 2024-03-13 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
| Bupropion Hydrochloride (XL) | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 2af578d8-a7f8-4da3-b126-390a0e950fad | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 210081 ANDA210081 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7863-9 | 68788786309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-9) | 2021-02-08 | 0000-00-00 | No | No | Current |