NDC 57664-292 - 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
- 57664-292
- Package NDCs from labels
- 57664-292-88, 57664-292-13, 57664-292-18
- 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 |
|---|---|---|---|---|---|---|
| 57664-292-13 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 57664-292-18 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 57664-292-88 | 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 |
|---|---|---|---|---|---|
| 57664-292-13 | EA - Each | 57664-292 | 8a3f05d6-d4fa-4baa-9e98-fa87cdd156a7 | 1 | 2013-02-13 |
| 57664-292-18 | EA - Each | 57664-292 | ab5e3a39-9978-400e-afba-13ffc98cd57f | 1 | 2013-02-13 |
| 57664-292-88 | EA - Each | 57664-292 | cfe65441-16b3-4fd6-be06-5db9797f5db1 | 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 | fded79a4-c354-448d-96dd-6dc69c46a013 | 2023-10-19 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 2cd15814-5f70-4c65-9f43-367495486ecd | 2023-10-18 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7ed13ef7-329e-40cb-b9b1-31a4bf32ac98 | 2023-08-29 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 96f9caa3-0d36-4d99-8c6f-0da5b0d03527 | 2023-08-11 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Unichem Pharmaceuticals (USA), Inc. | b9199878-3fb4-46dc-adbb-b3d9dc3852d4 | 2023-06-08 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | NCS HealthCare of KY, LLC dba Vangard Labs | 2927228a-7a3e-4e1d-ab5f-4407b00f6899 | 2023-05-31 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | edef7819-875f-4855-8f1f-32407f82e9dc | 2022-09-08 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Proficient Rx LP | b65d3089-0412-487f-a1b4-66f0bc6f398e | 2022-03-01 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | 9edc00c6-c281-4e81-b176-44b7536f71f2 | 2020-08-13 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | d9e5a8b9-1524-41b4-942f-f95015dd17f9 | 2020-08-05 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Teva Pharmaceuticals USA, Inc. | 5648c772-50cb-4961-996e-e68a8eb699ea | 2019-12-31 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | dd4b9972-0295-4555-a90b-bb087170cfbb | 2017-12-07 | Warnings, Adverse reactions | 197391 |
| BBA56C26-82C0-87D0-A1FE-1958C372A999 | 346af8fe-3816-49de-bfd3-5a7425e728f9 | 2007-03-30 | Warnings, Adverse reactions | BBA56C26-82C0-87D0-A1FE-1958C372A999 346af8fe-3816-49de-bfd3-5a7425e728f9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.