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#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Atlantic Biologicals Corp. | 50b3e7be-832b-313d-e063-6394a90a5ab4 | 2026-07-14 | Warnings, Adverse reactions | 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 |
| Baclofen | BACLOFEN | AvPAK | bc9040d9-1c54-9d62-e053-2a95a90a6ae3 | 2026-05-06 | Warnings, Adverse reactions | ANDA211659 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Coupler LLC | 5023c690-fd86-bb7d-e063-6394a90af6cd | 2026-04-23 | Warnings, Adverse reactions | ANDA211659 67046-1072-3 67046-1072 67046107203 197391 5023daca-e46c-c225-e063-6394a90ab41b 5023c690-fd86-bb7d-e063-6394a90af6cd H789N3FKE8 |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | O8232NY3SJ |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | O8232NY3SJ |
| Baclofen | BACLOFEN | Cardinal Health 107, LLC | 2278954a-7605-426a-ae85-1bf0a3117420 | 2026-04-22 | Warnings, Adverse reactions | 197391 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Golden State Medical Supply, Inc. | 32336e92-89a4-7d7f-e063-6394a90ae924 | 2026-04-21 | Warnings, Adverse reactions | 197391 430902 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ac9b720f-b755-49f1-9850-efb26feadaeb | 2026-04-14 | Warnings, Adverse reactions | 197391 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Cardinal Health 107, LLC | a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c | 2026-04-13 | Warnings, Adverse reactions | 197391 H789N3FKE8 |