Naproxen
- Product NDC
- 80425-0010
- 11-digit product format
- 804250010
- Labeler code
- 80425
- Product ID
- 80425-0010_2a982dd7-c530-0a5b-e063-6294a90aafd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA075927
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- Substance
- NAPROXEN
- Active strength
- 375 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198012 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0010-1 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0010 | NAPROXEN TABLET [ADVANCED RX OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250101_af9ad850-57b5-a21d-e053-2a95a90ae68e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0010-1 | 80425001001 | 60 TABLET in 1 BOTTLE (80425-0010-1) | 60 tablet | 2010-02-18 | 0000-00-00 | No | No | Current |