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 | Sagent Pharmaceuticals | ea32c39c-0ee3-4b5e-8da7-4c31db334bd8 | 2021-06-24 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Sagent Pharmaceuticals | 077aaf3b-1ca3-4599-a51a-6bbe39810ca8 | 2021-06-24 | Boxed warning, Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | 9edc00c6-c281-4e81-b176-44b7536f71f2 | 2020-08-13 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | d9e5a8b9-1524-41b4-942f-f95015dd17f9 | 2020-08-05 | Warnings, Adverse reactions | H789N3FKE8 |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Teva Pharmaceuticals USA, Inc. | 5648c772-50cb-4961-996e-e68a8eb699ea | 2019-12-31 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | dd4b9972-0295-4555-a90b-bb087170cfbb | 2017-12-07 | Warnings, Adverse reactions | H789N3FKE8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.