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#
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 | b5fde991-7d12-4083-a3d6-363718f1f6a1 | 2024-08-16 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Zydus Lifesciences Limited | bb5c6faa-2933-44d1-8706-8302150be734 | 2024-08-12 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Zydus Pharmaceuticals (USA) Inc. | cfc49176-8d01-4c39-9319-604dd087065c | 2024-08-12 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | NuCare Pharmaceuticals,Inc. | b2be2e6c-a247-30f4-e053-2a95a90a6ccb | 2024-07-17 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Direct_rx | 1bf59c3b-f8eb-972e-e063-6394a90aeccc | 2024-06-28 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 9834e409-8633-4f99-8ac7-7fa298d01c44 | 2024-05-30 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | 19b049cf-56a4-aeaa-e063-6394a90a366d | 2024-05-30 | Warnings, Adverse reactions | H789N3FKE8 |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | adc072b9-e48b-470d-9eb1-fd7b52c1f122 | 2024-05-29 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| BACLOFEN | BACLOFEN | TruPharma LLC | 68aa591e-ea98-4438-9a4a-4f7e9ea2b285 | 2024-04-17 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | d24135b3-e247-412f-a10b-ceecbdee3aef | 2024-04-02 | Warnings, Adverse reactions | ANDA212378 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80a4c6f7-4f02-493c-9263-62e1c90404ba | 2024-04-02 | Warnings, Adverse reactions | ANDA212378 H789N3FKE8 |
| BACLOFEN | BACLOFEN | Rising Pharma Holdings, Inc. | 6eb46715-d72b-473f-b984-90024033d4a0 | 2024-03-01 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7f27f935-b1fa-4494-9014-7f62c59bb8e3 | 2024-01-30 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f | 2024-01-30 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 402a0a2b-95a6-4d22-bedf-826e1f1cd2c3 | 2024-01-11 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b4506087-be24-4e76-9fb8-b07805137072 | 2024-01-10 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 54bea140-c537-44a2-8d1d-bfb20471f4d8 | 2024-01-10 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 12d57610-8c70-4729-b358-56525613a29d | 2024-01-10 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb | 2024-01-09 | Warnings, Adverse reactions | ANDA212378 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.