Bupropion Hydrochloride
- Product NDC
- 68071-1573
- 11-digit product format
- 680711573
- Labeler code
- 68071
- Product ID
- 68071-1573_ea3c3c24-7f4c-f517-e053-2995a90ade09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bupropion hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA205794
- Marketing category
- ANDA
- Marketing start
- 2018-04-20
- 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 | 68071-1573 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 68071-1573 | 68071-1573-3 | I | Inactivated by FDA | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-1573-3 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-1573-3 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-1573-3 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-1573-3 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205794-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | |
| A205794-002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | |
| A205794-003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205794-001 | AB1 |
| A205794-002 | AB1 |
| A205794-003 | 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 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-002 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-003 | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205794-001 | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2016-03-01 | 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 | A205794-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205794-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205794-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205794-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205794-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205794-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205794-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205794-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205794-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205794-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205794-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205794-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205794-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205794-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205794-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205794-001 | AB1 | 1 | 8072bd15b7f6… |
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 |
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-1573-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-ac9a-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-1573-3 | Bupropion HydrochlorideSR | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-1573 | BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 1 package rows | 20221005_ea3c460f-521e-7da9-e053-2a95a90a37ca.zip |
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 | REMEDYREPACK INC. | c76f2f9f-3999-4bdd-8ec3-e0066318d378 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Northwind Health Company, LLC | 0865f8cf-1d7f-0e67-e063-6294a90a2f4d | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 6701af43-bf7d-45c4-a331-a18d16bd68f7 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 21be6b3b-add3-43e7-af93-30350aefc89e | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | a72db723-df4b-4bf4-9bdc-05ae82058696 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | c37bb183-f272-4cae-96e1-7042c1dd7bcf | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | fd153957-ff74-4134-8545-cdc0e5619906 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | c0445fea-108f-4e00-a2ae-ebbdf2719947 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | d1d1ed19-e111-4652-a0d4-9406e6f73e9f | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | REMEDYREPACK INC. | b47c5515-a438-40bc-b8ad-26a6cf9676b7 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4bd469b8-fb35-0223-e063-6294a90ae7bc | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9d0608a1-0cc8-491a-ad91-238e0ea009fe | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Dr. Reddys Laboratories Inc. | ad784c8e-7201-4336-a310-616e3e979ca4 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | ScieGen Pharmaceuticals, Inc. | 092da413-ec60-4577-ac57-51e3e42d55c9 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Radha Pharmaceuticals, Inc. | 161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | eeb3fed1-2202-09fc-e053-2995a90a9f63 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 1094ff8e-f5a5-4a72-8bf9-25e68f5c964a | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
| BUPROPION HYDROCHLORIDE SR | BUPROPION HYDROCHLORIDE SR | DirectRx | dd4041cd-00e4-d10f-e053-2a95a90a5945 | 2025-01-22 | Warnings, Adverse reactions | 205794 ANDA205794 |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 339c7157-1c65-40d1-bbcc-c10348d908d3 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 205794 ANDA205794 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993518 | buPROPion HCl 150 MG 12HR Extended Release Oral Tablet | PSN | ea3c460f-521e-7da9-e053-2a95a90a37ca | 1 |
| 993518 | 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet | SCD | ea3c460f-521e-7da9-e053-2a95a90a37ca | 1 |
| 993518 | bupropion HCl 150 MG 12 HR Extended Release Oral Tablet | SY | ea3c460f-521e-7da9-e053-2a95a90a37ca | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-1573-3 | 68071157303 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68071-1573-3) | 2022-10-04 | 0000-00-00 | No | No | Current |