Naproxen
- Product NDC
- 68071-5039
- 11-digit product format
- 680715039
- Labeler code
- 68071
- Product ID
- 68071-5039_2d53b71b-770a-e12d-e063-6294a90a5478
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA204872
- Marketing category
- ANDA
- Marketing start
- 2019-01-01
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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 |
|---|
| 9TN87S3A3C | NAPROXEN SODIUM | 26159-34-2 | NAPROXEN SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-5039-1 | 68071503901 | 21 TABLET in 1 BOTTLE (68071-5039-1) | 21 tablet | 2023-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| gc 951-954L | NuCare Pharmaceuticals,Inc. | 2025-02-04 | HUMAN OTC DRUG LABEL | 3 |