NDC 57664-291-13 - 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
- 57664-291
- Requested NDC
- 57664-291-13
- Package NDCs from labels
- 57664-291-88, 57664-291-13, 57664-291-18
- Manufacturer
- CARACO PHARMACEUTICAL LABORATORIES, LTD.
- Effective date
- 2007-03-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen - CARACO PHARMACEUTICAL LABORATORIES, LTD. | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 2007-03-30 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2013-02-13 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57664-291-13 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 57664-291-18 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 57664-291-88 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-291-13 | EA - Each | 57664-291 | 25cacfb3-0de8-4531-98ba-44325dccd28b | 1 | 2013-02-13 |
| 57664-291-18 | EA - Each | 57664-291 | df28ad8c-1f0f-4381-9081-a6ec25590b0a | 1 | 2013-02-13 |
| 57664-291-88 | EA - Each | 57664-291 | 9567300e-95c0-47ef-9c9e-b5b8d6600484 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Baclofen | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| Baclofen | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | ||
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| microcrystalline cellulose | INACTIVE INGREDIENT | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | ||
| pregelatinized starch | INACTIVE INGREDIENT | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | ||
| sodium starch glycolate | INACTIVE INGREDIENT | BACLOFEN (BACLOFEN) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 |
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 | PHOENIX RX LLC | 45c6d45d-95d5-21b8-e063-6294a90a7955 | 2025-12-12 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Upsher-Smith Laboratories, LLC | b2747a9d-5fca-4657-9e4b-4112607f30d8 | 2025-12-11 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | SOLA Pharmaceuticals, LLC | 7b308b35-8c08-458d-860e-c78d057e8260 | 2025-12-08 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Proficient Rx LP | 0680301a-1649-46c4-b74e-ab03967945d0 | 2025-12-01 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2 | 2025-11-12 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Northstar RxLLC | 0aac77fa-30c2-46c8-a04d-e6b8333ddd81 | 2025-11-05 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | Major Pharmaceuticals | f328296e-0713-4acb-bcb5-c10d7838d380 | 2025-10-29 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 95755a7b-4a9f-45ea-a381-d3f661150efe | 2025-10-20 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | cfcf519f-5d15-431d-89c8-961a0c38ba60 | 2025-10-17 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 5cba5255-e5ad-48fd-8385-60e9ea6b6407 | 2025-10-09 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 0a5940cd-63eb-4d1b-8e92-44df264bc05a | 2025-10-03 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | ab5fd609-3081-4400-90cd-c83b6834d381 | 2025-10-03 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Marlex Pharmaceuticals Inc | 1b0f50c8-62e3-414d-96d3-5fd16e8043ab | 2025-09-22 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 844a09ab-6c11-44fa-a09b-09e2b7a3759e | 2025-08-25 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Asclemed USA, Inc. | 35bccefe-8d2e-85b5-e063-6394a90a58ca | 2025-08-13 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | American Health Packaging | 8b046ee6-28fc-4ab1-b543-414ad0103e5c | 2025-08-04 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Method Pharmaceuticals LLC | 1a9db542-d2b0-141a-e063-6394a90acc11 | 2025-07-23 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | a748da19-d3eb-499e-986c-2043a1356f2b | 2025-07-15 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | A-S Medication Solutions | eb690a49-b87b-433f-9afe-2966406fe00e | 2025-07-15 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | A-S Medication Solutions | af0ade6c-9dd4-42d3-879e-4201fbe585ee | 2025-07-15 | Warnings, Adverse reactions | 197391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.