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 | Aphena Pharma Solutions - Tennessee, LLC | 39ad22ca-f034-f605-e063-6294a90a08e4 | 2025-07-11 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | 3981db3e-672c-1634-e063-6294a90a4cd1 | 2025-07-09 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 3ac0f0d2-86d8-46d0-88e5-c243734b0814 | 2025-06-26 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | HAWAII REPACK, INC. | bc48a775-1feb-44c4-9453-e1ccf3d929bd | 2025-06-11 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | 4679a275-9307-4b0f-a2eb-2d83227ea84d | 2025-06-11 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 8cb96e7b-9c40-46a9-b964-7a573b7a0342 | 2025-02-21 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | XLCare Pharmaceuticals Inc. | 2b4908fb-47b5-4675-be9e-ca1ad48a7252 | 2025-02-05 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals,Inc. | fd00fa8f-2797-c3f0-e053-6294a90a975f | 2025-02-05 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2cf71f5f-6d46-7506-e063-6294a90a186f | 2025-01-30 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Direct_Rx | 020632f4-5e8a-f4a0-e063-6294a90a6301 | 2025-01-28 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2 | 2025-01-22 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Asclemed USA, Inc. | 687f48da-bc41-4700-9513-77a32fc86c93 | 2025-01-15 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c534d-4fa3-0a2f-e053-2995a90ab52f | 2024-12-31 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c4164-e607-2e27-e053-2a95a90ad7db | 2024-12-31 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | b4f2f888-979a-6f54-e053-2a95a90a95a3 | 2024-12-31 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a1884-f46f-5cd4-e053-2a95a90a3e27 | 2024-12-31 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a9d82-1d61-aeec-e053-2995a90a03a4 | 2024-12-31 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | ec09736a-dd2b-0a3b-e053-2995a90a9542 | 2024-12-31 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a58145a-57f9-6bb1-e063-6294a90a32a8 | 2024-12-29 | Warnings, Adverse reactions | 197392 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a586399-49e9-1e5c-e063-6294a90a4872 | 2024-12-28 | Warnings, Adverse reactions | 197392 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.