Naproxen
- Product NDC
- 71610-591
- 11-digit product format
- 716100591
- Labeler code
- 71610
- Product ID
- 71610-591_705546f2-9f9c-4b26-b5a6-f3d32bc92c60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2021-06-04
- 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, 198013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-591-53 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71610-591-80 | Naproxen | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-591 | NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210822_9c963e77-6e05-47d0-a8d3-e581777377b9.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 |
|---|
| 71610-591-53 | 71610059153 | 60 TABLET in 1 BOTTLE (71610-591-53) | 60 tablet | 2021-08-09 | 0000-00-00 | No | No | Current |
| 71610-591-80 | 71610059180 | 180 TABLET in 1 BOTTLE (71610-591-80) | 180 tablet | 2021-08-09 | 0000-00-00 | No | No | Current |