NDC 80425-0104-01 - Nabumetone
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
- 80425-0104
- Requested NDC
- 80425-0104-01
- Package NDCs from labels
- 80425-0104-1, 80425-0104-2, 80425-0104-3, 80425-0104-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nabumetone - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0104-1 | Nabumetone | 30 in 1 BOTTLE | TABLET | 30 | 6 | |
| 80425-0104-2 | Nabumetone | 60 in 1 BOTTLE | TABLET | 60 | 6 | |
| 80425-0104-3 | Nabumetone | 90 in 1 BOTTLE | TABLET | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0104 | NABUMETONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250101_b43db4aa-6013-3942-e053-2a95a90a5189.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0104-1 | EA - Each | 80425-0104 | 8347823d-cf0f-4cb3-a810-a841e122579b | 1 | 2023-06-06 |
| 80425-0104-2 | EA - Each | 80425-0104 | eb7213a9-c436-4260-9a66-76a9d1e34c2e | 1 | 2023-06-06 |
| 80425-0104-3 | EA - Each | 80425-0104 | ae4759d9-08ef-477f-86f2-95f67785c7fc | 1 | 2023-06-06 |
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 |
|---|---|---|---|---|---|---|
| Nabumetone | NABUMETONE | Westminster Pharmaceuticals, LLC | 264df44a-e294-4d9b-9113-92859cb08c20 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | ANDA078420 311893 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 62f2e0bf-e5c8-480c-ac5e-401ced3bbc67 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | ANDA078420 311892 LW0TIW155Z |
| RELAFEN DS | NABUMETONE | Carwin Pharmaceutical Associates, LLC | a9a0af85-6c43-4a2d-ba75-0be4ca64c931 | 2024-01-08 | Boxed warning, Warnings, Adverse reactions | LW0TIW155Z |
| Nabumetone | NABUMETONE | Lupin Pharmaceuticals, Inc. | cf96d189-5417-4181-a5fb-169b269560a2 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | 311893 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Chartwell RX, LLC | 84bb2887-bab4-46ae-a07c-fa2a32c04b50 | 2023-01-20 | Boxed warning, Warnings, Adverse reactions | 311893 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Proficient Rx LP | 0870c3c9-bfce-4722-8779-8775644196d3 | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Proficient Rx LP | 7a1643bf-6627-4b12-8246-6acc40517cf2 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | ANDA078420 311893 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Proficient Rx LP | f4392863-ed3f-4fbd-8260-49827609aa2e | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | ANDA078420 311893 LW0TIW155Z |
| Nabumetone | NABUMETONE | Asclemed USA, Inc. | 04a71deb-2c9d-436c-a574-e5991b6a5248 | 2022-03-07 | Boxed warning, Warnings, Adverse reactions | ANDA078420 311892 LW0TIW155Z |
| Nabumetone | NABUMETONE | Proficient Rx LP | 079a8a9e-6d71-414a-83f3-ef68e323c1fd | 2020-01-01 | Boxed warning, Warnings, Adverse reactions | 311893 LW0TIW155Z |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.