NDC 57664-291 - 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
- 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 |
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 | Bryant Ranch Prepack | 9834e409-8633-4f99-8ac7-7fa298d01c44 | 2024-05-30 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | 19b049cf-56a4-aeaa-e063-6394a90a366d | 2024-05-30 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | adc072b9-e48b-470d-9eb1-fd7b52c1f122 | 2024-05-29 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | TruPharma LLC | 68aa591e-ea98-4438-9a4a-4f7e9ea2b285 | 2024-04-17 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | d24135b3-e247-412f-a10b-ceecbdee3aef | 2024-04-02 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80a4c6f7-4f02-493c-9263-62e1c90404ba | 2024-04-02 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Rising Pharma Holdings, Inc. | 6eb46715-d72b-473f-b984-90024033d4a0 | 2024-03-01 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7f27f935-b1fa-4494-9014-7f62c59bb8e3 | 2024-01-30 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f | 2024-01-30 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 402a0a2b-95a6-4d22-bedf-826e1f1cd2c3 | 2024-01-11 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b4506087-be24-4e76-9fb8-b07805137072 | 2024-01-10 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 54bea140-c537-44a2-8d1d-bfb20471f4d8 | 2024-01-10 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 12d57610-8c70-4729-b358-56525613a29d | 2024-01-10 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb | 2024-01-09 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | A-S Medication Solutions | e163e7dc-45a5-43c2-b13d-a4453f2c360c | 2023-12-05 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 081d478a-2f3f-456e-bcca-00487589da6f | 2023-12-05 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 58816b46-28a5-48e2-b89d-98df65939386 | 2023-10-20 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 9110b1cb-8604-4824-9337-84b08d41dd3c | 2023-10-20 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | f9cf294a-85d1-4321-af68-4279b20c4b71 | 2023-10-19 | Warnings, Adverse reactions | 197391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.