| NDC Code | 54868-3974-1 |
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-3974-1) |
| Product NDC | 54868-3974 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Naprelan |
| Non-Proprietary Name | Naproxen Sodium |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20050819 |
| Marketing Category Name | NDA |
| Application Number | NDA020353 |
| Manufacturer | Physicians Total Care, Inc. |
| Substance Name | NAPROXEN SODIUM |
| Strength | 375 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |