Product NDC: | 21695-425 |
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: | 21695-425 |
Labeler Name: | Rebel Distributors Corp. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020607 |
Marketing Category: | NDA |
Start Marketing Date: | 19971224 |
Package NDC: | 21695-425-60 |
Package Description: | 60 TABLET, FILM COATED in 1 BOTTLE (21695-425-60) |
NDC Code | 21695-425-60 |
Proprietary Name | ARTHROTEC |
Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (21695-425-60) |
Product NDC | 21695-425 |
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 | Rebel Distributors Corp. |
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] |