Baclofen
- Product NDC
- 42192-631
- Requested package NDC
- 42192-631-40
- 11-digit product format
- 421920631
- Labeler code
- 42192
- Product ID
- 42192-631_5d57932e-eed9-096d-e063-6294a90a1c19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Application
- NDA208193
- Marketing category
- NDA
- Marketing start
- 2026-10-26
- Substance
- BACLOFEN
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| N208193-001 | OZOBAX | BACLOFEN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2019-09-18 | |
| N208193-002 | OZOBAX DS | BACLOFEN | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N208193-002 | AA |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208193-001 | OZOBAX | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2019-09-18 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N208193-001 | OZOBAX | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2019-09-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2023-10-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD | 2019-09-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208193-002 | OZOBAX DS | 10MG/5ML | SOLUTION / ORAL | RLD, RS | 2023-10-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208193-001 | OZOBAX | 5MG/5ML | SOLUTION / ORAL | RLD, RS | 2019-09-18 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208193-002 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N208193-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N208193-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208193-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208193-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208193-002 | AA | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208193-002 | AA | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208193-001 | 10610502 | 2039-08-30 | U-2779 | 2020-04-23 | a50c72e98297… |
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
- Baclofen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACLOFEN | 10 mg/5mL |
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 | Atlantic Biologicals Corp. | 50b3e7be-832b-313d-e063-6394a90a5ab4 | 2026-09-04 | Warnings, Adverse reactions | 208193 NDA208193 |
| OZOBAX DS | BACLOFEN | Rosemont Pharmaceuticals LLC | d8ddcec5-debe-42b4-a803-e65917cc6a54 | 2026-03-13 | Warnings, Adverse reactions | 208193 NDA208193 |
| Baclofen | BACLOFEN | Palmetto Pharmaceuticals Inc. | 2422746c-afec-ad30-e063-6394a90a0403 | 2025-12-31 | Warnings, Adverse reactions | 208193 NDA208193 |
| Baclofen | BACLOFEN | TRUPHARMA, LLC | f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7 | 2023-10-18 | Warnings, Adverse reactions | 208193 NDA208193 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42192-631-40 | 42192063140 | 40 CUP, UNIT-DOSE in 1 CASE (42192-631-40) / 10 mL in 1 CUP, UNIT-DOSE (42192-631-10) | 2026-10-26 | No | No | Current |