Naproxen Sodium
- Product NDC
- 0480-0951
- 11-digit product format
- 004800951
- Labeler code
- 0480
- Product ID
- 0480-0951_6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naproxen sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA075416
- Marketing category
- ANDA
- Marketing start
- 2022-11-01
- Substance
- NAPROXEN SODIUM
- 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
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-0951-01 | 00480095101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01) | 2022-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen Sodium | Teva Pharmaceuticals, Inc. | 2024-12-30 | HUMAN PRESCRIPTION DRUG LABEL | 6 |