Naproxen
- Product NDC
- 50090-5645
- 11-digit product format
- 500905645
- Labeler code
- 50090
- Product ID
- 50090-5645_35a43392-eb57-4493-be32-5c7e74b2fdd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- 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 |
|---|
| 50090-5645-0 | 50090564500 | 15 TABLET in 1 BOTTLE (50090-5645-0) | 15 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-1 | 50090564501 | 20 TABLET in 1 BOTTLE (50090-5645-1) | 20 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-2 | 50090564502 | 30 TABLET in 1 BOTTLE (50090-5645-2) | 30 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-4 | 50090564504 | 14 TABLET in 1 BOTTLE (50090-5645-4) | 14 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-5 | 50090564505 | 40 TABLET in 1 BOTTLE (50090-5645-5) | 40 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-6 | 50090564506 | 100 TABLET in 1 BOTTLE (50090-5645-6) | 100 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-7 | 50090564507 | 60 TABLET in 1 BOTTLE (50090-5645-7) | 60 tablet | 2021-09-13 | No | No | Historical |
| 50090-5645-9 | 50090564509 | 6 TABLET in 1 BOTTLE (50090-5645-9) | 6 tablet | 2021-09-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | A-S Medication Solutions | 2025-05-07 | HUMAN PRESCRIPTION DRUG LABEL | 5 |