NAPROXEN SODIUM
- Product NDC
- 68210-4096
- 11-digit product format
- 682104096
- Labeler code
- 68210
- Product ID
- 68210-4096_2a8235d0-4618-0572-e063-6394a90a0d1a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SPIRIT PHARMACEUTICALS,LLC
- Application
- ANDA091353
- Marketing category
- ANDA
- Marketing start
- 2020-07-02
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68210-4096-1 | 68210409601 | 365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1) | 2020-07-02 | No | No | Historical |