| Product NDC: | 68210-0400 |
| Proprietary Name: | NAPROXEN SODIUM |
| Non Proprietary Name: | NAPROXEN SODIUM |
| Active Ingredient(s): | 220 mg/1 & nbsp; NAPROXEN SODIUM |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68210-0400 |
| Labeler Name: | SPIRIT PHARMACEUTICALS,LLC |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA090545 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110801 |
| Package NDC: | 68210-0400-0 |
| Package Description: | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-0400-0) |
| NDC Code | 68210-0400-0 |
| Proprietary Name | NAPROXEN SODIUM |
| Package Description | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-0400-0) |
| Product NDC | 68210-0400 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | NAPROXEN SODIUM |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20110801 |
| Marketing Category Name | ANDA |
| Labeler Name | SPIRIT PHARMACEUTICALS,LLC |
| Substance Name | NAPROXEN SODIUM |
| Strength Number | 220 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |