NDC 80425-0282-01 - 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
- 80425-0282
- Requested NDC
- 80425-0282-01
- Package NDCs from labels
- 80425-0282-2, 80425-0282-1, 80425-0282-3, 80425-0282-4, 80425-0282-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-11-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Baclofen - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-11-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0282-1 | Baclofen | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 80425-0282-2 | Baclofen | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 80425-0282-3 | Baclofen | 90 in 1 BOTTLE | TABLET | 90 | 2 | |
| 80425-0282-4 | Baclofen | 120 in 1 BOTTLE | TABLET | 120 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0282 | BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 4 package rows | 20241116_f5edb656-4f7e-2386-e053-2995a90a70de.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0282-1 | EA - Each | 80425-0282 | 6dc60c48-2657-425f-bc48-f4f288971577 | 1 | 2023-04-07 |
| 80425-0282-2 | EA - Each | 80425-0282 | 42f8d368-b537-40b6-9557-e8544b27c1ca | 1 | 2023-04-07 |
| 80425-0282-3 | EA - Each | 80425-0282 | b6333d87-6abb-4774-9644-0242ac576cf1 | 1 | 2023-04-07 |
| 80425-0282-4 | EA - Each | 80425-0282 | f179f3fc-b772-4532-8048-9a3dba92b73c | 1 | 2024-12-10 |
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 | 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 | ANDA212378 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 | H789N3FKE8 |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals, Inc. | 2517f71f-f452-1f56-e063-6394a90a6ef1 | 2026-06-25 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | Redpharm Drug | 53df4b4b-842e-9e3a-e063-6394a90a8a3d | 2026-06-10 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | d689d32c-12a7-4ae4-afc3-8a353be67148 | 2026-06-01 | Warnings, Adverse reactions | ANDA212378 H789N3FKE8 |
| Baclofen | BACLOFEN | Eywa Pharma Inc | 7ec59f6b-7c4f-432d-ba27-442861806b6c | 2026-05-16 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | e017a001-8cb1-4dd8-960e-c6d74005f57f | 2026-05-12 | Warnings, Adverse reactions | 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 | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Coupler LLC | 5023c690-fd86-bb7d-e063-6394a90af6cd | 2026-04-23 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Cardinal Health 107, LLC | 2278954a-7605-426a-ae85-1bf0a3117420 | 2026-04-22 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Golden State Medical Supply, Inc. | 32336e92-89a4-7d7f-e063-6394a90ae924 | 2026-04-21 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ac9b720f-b755-49f1-9850-efb26feadaeb | 2026-04-14 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | Cardinal Health 107, LLC | a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c | 2026-04-13 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 355266e4-68f7-47d7-9f4e-1a0fc912786d | 2026-04-10 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Medcore LLC | 13eca70c-3cc8-4317-83cf-ade3327e48c0 | 2026-04-01 | Warnings, Adverse reactions | 197392 H789N3FKE8 |