| NDC Code | 68210-0400-0 |
| Package Description | 1 BOTTLE in 1 CARTON (68210-0400-0) > 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| Product NDC | 68210-0400 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Naproxen Sodium |
| Non-Proprietary Name | Naproxen Sodium |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20171122 |
| Marketing Category Name | ANDA |
| Application Number | ANDA090545 |
| Manufacturer | SPIRIT PHARMACEUTICALS,LLC |
| Substance Name | NAPROXEN SODIUM |
| Strength | 220 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |