| Product NDC: | 16590-024 |
| Proprietary Name: | ARTHROTEC |
| Non Proprietary Name: | DICLOFENAC SODIUM AND MISOPROSTOL |
| Active Ingredient(s): | 75; 200 mg/1; ug/1 & nbsp; DICLOFENAC SODIUM AND MISOPROSTOL |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-024 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020607 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19971224 |
| Package NDC: | 16590-024-30 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (16590-024-30) |
| NDC Code | 16590-024-30 |
| Proprietary Name | ARTHROTEC |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (16590-024-30) |
| Product NDC | 16590-024 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | DICLOFENAC SODIUM AND MISOPROSTOL |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 19971224 |
| Marketing Category Name | NDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
| Strength Number | 75; 200 |
| Strength Unit | mg/1; ug/1 |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] |