NDC 67046-1072-03 - 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
- 67046-1072
- Requested NDC
- 67046-1072-03
- Package NDCs from labels
- 67046-1072-3, 67046-1072-03
- Manufacturer
- Coupler LLC | Zydus Lifesciences Global FZE
- Effective date
- 2026-04-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen - Coupler LLC | Zydus Lifesciences Global FZE | Coupler LLC | Zydus Lifesciences Global FZE | 2026-04-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-1072-3 | Baclofen | 30 in 1 BLISTER PACK | TABLET | 30 | 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 | REMEDYREPACK INC. | ab3760cd-a84b-49ba-88e3-b9ea73c55f82 | 2026-09-09 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Atlantic Biologicals Corp. | 50b3e7be-832b-313d-e063-6394a90a5ab4 | 2026-09-04 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 4e2cd27d-91c7-4f15-96cc-3971769dbeaa | 2026-09-03 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | c2e1d183-7061-459b-a631-206b06d12753 | 2026-09-01 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Par Health USA, LLC | c17527be-661d-42f5-b6f6-56a681ba7870 | 2026-08-24 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | aeb56b0e-7126-4417-b726-e8a54f73de3f | 2026-08-24 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ac9b720f-b755-49f1-9850-efb26feadaeb | 2026-08-14 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 355266e4-68f7-47d7-9f4e-1a0fc912786d | 2026-08-10 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | 76896b07-2835-4467-b386-87ec66ddd88e | 2026-08-04 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Cardinal Health 107, LLC | 3c87e116-871d-46b8-897b-fc27a17b988d | 2026-07-24 | Warnings, Adverse reactions | ANDA211659 430902 H789N3FKE8 |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals Inc. | 3047613d-006b-4011-b5fe-098588f474aa | 2026-07-22 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | 6274e70a-fb57-461b-b1bc-39d4ff916b2a | 2026-07-14 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74 | 2026-06-30 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | AvPAK | c21095a9-17b1-555a-e053-2a95a90a51fd | 2026-06-29 | Warnings, Adverse reactions | ANDA211659 430902 H789N3FKE8 |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals, Inc. | 2517f71f-f452-1f56-e063-6394a90a6ef1 | 2026-06-25 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Redpharm Drug | 53df4b4b-842e-9e3a-e063-6394a90a8a3d | 2026-06-10 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | d689d32c-12a7-4ae4-afc3-8a353be67148 | 2026-06-01 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| Baclofen | BACLOFEN | Eywa Pharma Inc | 7ec59f6b-7c4f-432d-ba27-442861806b6c | 2026-05-16 | Warnings, Adverse reactions | 197391 430902 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | e017a001-8cb1-4dd8-960e-c6d74005f57f | 2026-05-12 | Warnings, Adverse reactions | 430902 H789N3FKE8 |
| Gablofen | BACLOFEN INJECTION | Piramal Critical Care Inc | 00d3e846-dd92-448d-9ab8-6a07be823cc1 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.