NDC 57664-291-18 - 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
- 57664-291-18
- 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 | Medcore LLC | 13eca70c-3cc8-4317-83cf-ade3327e48c0 | 2026-04-01 | Warnings, Adverse reactions | 197391 197392 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | ee59a379-17d5-487f-b72f-a53e74744a70 | 2026-03-27 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 16266972-843e-4ea5-be1f-fb1b1588a5dc | 2026-03-25 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | 0a1d09ac-94d5-45ef-92cc-bc261c2b2d75 | 2026-03-25 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 4f84b27a-725a-48e6-a58a-85bbb395f4ae | 2026-03-23 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | d20cc8b2-5236-4c87-b395-0acaaf7b62dd | 2026-03-19 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 5f6a86f9-9658-4210-a47c-62907edfd416 | 2026-03-19 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 5e479876-adfb-4590-ac10-3924ff7988b0 | 2026-03-18 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Preferred Pharmaceuticals Inc. | 3fdfeef9-68b3-4f6c-a4de-28179758a962 | 2026-03-18 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Redpharm Drug | 4ce1de84-72e1-57d3-e063-6294a90a220f | 2026-03-13 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Lifestar Pharma LLC | f9dd1b55-2984-446a-8146-2ab0f5211e15 | 2026-02-27 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 7ee42a29-21c2-47f8-a5b3-f3af115b665d | 2026-02-24 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals, Inc. | 58416ceb-994f-4571-afbd-c2171823f528 | 2026-01-26 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Advagen Pharma Limited | 04dac0f6-cc6c-4959-9bca-a6e4a99690f3 | 2026-01-23 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals Inc. | 69d0027a-cb46-4754-9225-071ec1ce4b37 | 2026-01-21 | Warnings, Adverse reactions | 197391 |
| Baclofen | BACLOFEN | A-S Medication Solutions | 975fda6d-d929-482b-8be7-60849026dbdd | 2026-01-20 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 808113db-c5c2-404c-ab5f-62b991641cfe | 2026-01-12 | Warnings, Adverse reactions | 197392 |
| Baclofen | BACLOFEN | Major Pharmaceuticals | ae732bdc-5178-4565-8219-d1787a5211a6 | 2026-01-09 | Warnings, Adverse reactions | 197391 197392 |
| Baclofen | BACLOFEN | Northwind Health Company, LLC | 06bcfb08-2ada-f803-e063-6394a90a826b | 2025-12-26 | Warnings, Adverse reactions | 197391 |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 459ec5f5-4f99-e917-e063-6294a90a23cd | 2025-12-18 | Warnings, Adverse reactions | 197391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.