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 | Advanced Rx of Tennessee, LLC | 29987a4c-cf5f-4f98-e063-6394a90a7f19 | 2024-12-19 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Quality Care Products, LLC | 67df80a6-7fff-496e-9a89-d43a06c2a11f | 2024-12-19 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7b6d33d8-58c2-448d-a8df-1de7339b1520 | 2024-12-12 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4cbb2264-ef65-4906-86e5-349deeeda7a9 | 2024-12-05 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 32525b4e-6384-49e1-a66d-abe45484ab86 | 2024-12-05 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | e13c0563-0f32-4199-acb0-ad2376ec951b | 2024-12-05 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | f5edb656-4f7e-2386-e053-2995a90a70de | 2024-11-15 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Chartwell RX, LLC | 2a75db96-590a-43cf-aefb-3bbcb287dbf0 | 2024-10-10 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Proficient Rx LP | b981eb16-a195-41da-a186-3e91b63b2def | 2024-10-01 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Proficient Rx LP | 9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc | 2024-10-01 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | f9c6d75a-a956-47b6-a5a2-deaf9797e2b2 | 2024-09-16 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 08a6866f-b127-482f-9f22-113175487bdd | 2024-09-12 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 5b92b0a6-ebba-4815-8b94-f2014674399b | 2024-09-05 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4634093b-6def-41d6-a7f3-23040125c4f4 | 2024-09-03 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 655db2a3-daf7-4f4b-8f64-4a6d81fdc165 | 2024-09-03 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b5fde991-7d12-4083-a3d6-363718f1f6a1 | 2024-08-16 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Zydus Lifesciences Limited | bb5c6faa-2933-44d1-8706-8302150be734 | 2024-08-12 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Zydus Pharmaceuticals (USA) Inc. | cfc49176-8d01-4c39-9319-604dd087065c | 2024-08-12 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | NuCare Pharmaceuticals,Inc. | b2be2e6c-a247-30f4-e053-2a95a90a6ccb | 2024-07-17 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Direct_rx | 1bf59c3b-f8eb-972e-e063-6394a90aeccc | 2024-06-28 | Warnings, Adverse reactions | 197392 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.