BACLOFEN
- Product NDC
- 70934-918
- 11-digit product format
- 709340918
- Labeler code
- 70934
- Product ID
- 70934-918_f06e527b-159e-29d9-e053-2a95a90aab35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2021-11-04
- Marketing end
- 2024-05-31
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 70934-918 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 70934-918 | 70934-918-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 70934-918 | 70934-918-60 | 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 | 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 | 70934-918-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70934-918-30 | 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 | 70934-918-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70934-918-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209102-001 | BACLOFEN | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-002 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-003 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | |
| A209102-004 | BACLOFEN | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209102-001 | AB |
| A209102-002 | AB |
| A209102-003 | AB |
| A209102-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-001 | BACLOFEN | 5MG | TABLET / ORAL | AB | RS | 2017-11-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2017-11-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-003 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2017-11-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-004 | BACLOFEN | 15MG | TABLET / ORAL | AB | 2024-02-05 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209102-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209102-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209102-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209102-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209102-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209102-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209102-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209102-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209102-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209102-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209102-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ac9b720f-b755-49f1-9850-efb26feadaeb | 2026-08-14 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Redpharm Drug | 53df4b4b-842e-9e3a-e063-6394a90a8a3d | 2026-06-10 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | e017a001-8cb1-4dd8-960e-c6d74005f57f | 2026-05-12 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | ee59a379-17d5-487f-b72f-a53e74744a70 | 2026-03-27 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 91175128-8285-4d04-89a9-219781be9260 | 2026-03-25 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 16266972-843e-4ea5-be1f-fb1b1588a5dc | 2026-03-25 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 0a1d09ac-94d5-45ef-92cc-bc261c2b2d75 | 2026-03-25 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Major Pharmaceuticals | 46f84504-ffc4-4be5-9598-c20a3f4210f4 | 2026-02-13 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Advagen Pharma Limited | 04dac0f6-cc6c-4959-9bca-a6e4a99690f3 | 2026-01-23 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 00c6c924-ddfd-4a75-afd7-f6561ff9abbc | 2026-01-21 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 459ec5f5-4f99-e917-e063-6294a90a23cd | 2025-12-18 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | SOLA Pharmaceuticals, LLC | 7b308b35-8c08-458d-860e-c78d057e8260 | 2025-12-08 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Proficient Rx LP | 0680301a-1649-46c4-b74e-ab03967945d0 | 2025-12-01 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 5cba5255-e5ad-48fd-8385-60e9ea6b6407 | 2025-10-09 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 4e2cd27d-91c7-4f15-96cc-3971769dbeaa | 2025-10-01 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Asclemed USA, Inc. | 35bccefe-8d2e-85b5-e063-6394a90a58ca | 2025-08-13 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | A-S Medication Solutions | eb690a49-b87b-433f-9afe-2966406fe00e | 2025-07-15 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | A-S Medication Solutions | af0ade6c-9dd4-42d3-879e-4201fbe585ee | 2025-07-15 | Warnings, Adverse reactions | 209102 ANDA209102 |
| BACLOFEN | BACLOFEN | Proficient Rx LP | 0243dd97-1d40-48f7-8853-76e046c605f2 | 2025-04-01 | Warnings, Adverse reactions | 209102 ANDA209102 |
| Baclofen | BACLOFEN | Direct_Rx | 020632f4-5e8a-f4a0-e063-6294a90a6301 | 2025-01-28 | Warnings, Adverse reactions | 209102 ANDA209102 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-918-30 | 70934091830 | 30 TABLET in 1 BOTTLE, PLASTIC (70934-918-30) | 30 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70934-918-60 | 70934091860 | 60 TABLET in 1 BOTTLE, PLASTIC (70934-918-60) | 60 tablet | 2022-03-18 | 0000-00-00 | No | No | Current |