Naproxen
- Product NDC
- 71610-597
- 11-digit product format
- 716100597
- Labeler code
- 71610
- Product ID
- 71610-597_b86a9e2f-2e2c-4ca7-b3d7-2615e53ae369
- 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
- 500 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 57Y76R9ATQ | NAPROXEN | 22204-53-1 | NAPROXEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-597-53 | 71610059753 | 60 TABLET in 1 BOTTLE (71610-597-53) | 60 tablet | 2021-10-26 | No | No | Historical |
| 71610-597-70 | 71610059770 | 120 TABLET in 1 BOTTLE (71610-597-70) | 120 tablet | 2021-09-09 | No | No | Historical |
| 71610-597-80 | 71610059780 | 180 TABLET in 1 BOTTLE (71610-597-80) | 180 tablet | 2021-10-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | Aphena Pharma Solutions - Tennessee, LLC | 2021-11-10 | HUMAN PRESCRIPTION DRUG LABEL | 2 |