NDC 80425-0049-01 - Naproxen
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
- 80425-0049
- Requested NDC
- 80425-0049-01
- Package NDCs from labels
- 80425-0049-4, 80425-0049-2, 80425-0049-1, 80425-0049-3, 80425-0049-01
- Manufacturer
- Advanced Rx 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 |
|---|---|---|---|
| Naproxen - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0049-1 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | 8 | |
| 80425-0049-2 | Naproxen | 90 in 1 BOTTLE | TABLET | 90 | 8 | |
| 80425-0049-3 | Naproxen | 30 in 1 BOTTLE | TABLET | 30 | 8 | |
| 80425-0049-4 | Naproxen | 120 in 1 BOTTLE | TABLET | 120 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0049 | NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250101_af9a94a8-3825-eabd-e053-2a95a90acd58.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0049-1 | EA - Each | 80425-0049 | f59baca6-2df7-457a-b759-62a26ac8d372 | 1 | 2023-04-07 |
| 80425-0049-2 | EA - Each | 80425-0049 | e58110de-d87f-4f2c-992d-e790c9d4b948 | 1 | 2023-04-07 |
| 80425-0049-3 | EA - Each | 80425-0049 | 90e9f4b8-c983-428a-af1e-5a9e5ab23cfe | 1 | 2023-04-07 |
| 80425-0049-4 | EA - Each | 80425-0049 | 48b6443c-efb0-41ea-9207-848fc1dcb2b9 | 1 | 2023-04-07 |
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 |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN | Cipla USA Inc. | e06c2b43-9882-442e-8413-10d9a33aecb9 | 2019-08-26 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | TIME CAP LABORATORIES | 4350a2d9-5228-460e-b7b1-27e8fa846787 | 2018-10-09 | Warnings | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | e2347581-90da-429a-b17c-cffd0039fb86 | 2017-10-23 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | NCS HealthCare of KY, Inc dba Vangard Labs | 62a12771-bde9-4bc3-9ce9-672c8e31f020 | 2017-10-12 | Boxed warning, Warnings, Adverse reactions | ANDA075927 198014 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.