NDC 58657-930-10 - Baclofen
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 58657-930
- Requested NDC
- 58657-930-10
- Package NDCs from labels
- 58657-930-10, 58657-930-05, 58657-930-01
- Manufacturer
- Method Pharmaceuticals LLC
- Effective date
- 2025-07-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen - Method Pharmaceuticals LLC | Method Pharmaceuticals LLC | 2025-07-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-930-01 | Baclofen | 10 in 1 CARTON | TABLET | 10 | 2 | |
| 58657-930-05 | Baclofen | 5 in 1 CARTON | TABLET | 5 | 2 | |
| 58657-930-10 | Baclofen | 10 in 1 BLISTER PACK | TABLET | 10 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-930-01 | EA - Each | 58657-930 | 4985a946-9e76-44b2-b50c-34df4dd89ad0 | 1 | 2025-09-12 |
| 58657-930-05 | EA - Each | 58657-930 | 04d4a779-6a5a-4d86-8fef-5ea89974731e | 1 | 2025-09-12 |
| 58657-930-10 | EA - Each | 58657-930 | a66e2ba8-6129-49c7-b3d7-d17c3e3483d1 | 1 | 2025-11-13 |
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 | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | e163e7dc-45a5-43c2-b13d-a4453f2c360c | 2023-12-05 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 081d478a-2f3f-456e-bcca-00487589da6f | 2023-12-05 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen (Intrathecal) | BACLOFEN | MAIA Pharmaceuticals, Inc. | 11ba5575-a856-414a-89f8-17f3a01de55b | 2023-11-08 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 58816b46-28a5-48e2-b89d-98df65939386 | 2023-10-20 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 9110b1cb-8604-4824-9337-84b08d41dd3c | 2023-10-20 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | f9cf294a-85d1-4321-af68-4279b20c4b71 | 2023-10-19 | Warnings, Adverse reactions | ANDA212378 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fded79a4-c354-448d-96dd-6dc69c46a013 | 2023-10-19 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 2cd15814-5f70-4c65-9f43-367495486ecd | 2023-10-18 | Warnings, Adverse reactions | ANDA212378 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | TRUPHARMA, LLC | f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7 | 2023-10-18 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7ed13ef7-329e-40cb-b9b1-31a4bf32ac98 | 2023-08-29 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 96f9caa3-0d36-4d99-8c6f-0da5b0d03527 | 2023-08-11 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Slayback Pharma LLC | 9fad5ffc-afae-4c92-a672-ee636df45bc5 | 2023-06-16 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Unichem Pharmaceuticals (USA), Inc. | b9199878-3fb4-46dc-adbb-b3d9dc3852d4 | 2023-06-08 | Warnings, Adverse reactions | 197391 430902 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | NCS HealthCare of KY, LLC dba Vangard Labs | 2927228a-7a3e-4e1d-ab5f-4407b00f6899 | 2023-05-31 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| LYVISPAH | BACLOFEN | Amneal Pharmaceuticals LLC | f8992a56-9010-4c4b-84d5-ddcc3e2c3317 | 2023-04-23 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | MAlA Pharmaceuticals, Inc. | e05080ef-53d9-4060-aaa4-86a6935467de | 2023-03-14 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | MAlA Pharmaceuticals, Inc. | dfa6148c-693c-45f1-89be-0e77d39f313e | 2023-01-15 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Lioresal (baclofen) | BACLOFEN | Amneal Pharmaceuticals LLC | 6f3bdcc0-ffc8-4911-8c35-958c8103a2c5 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | edef7819-875f-4855-8f1f-32407f82e9dc | 2022-09-08 | Warnings, Adverse reactions | ANDA212378 197391 H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.