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Diclofenac Sodium and Misoprostol
Diclofenac Sodium and Misoprostol - 0591-0397-60 - (Diclofenac Sodium and Misoprostol)
Drug Information of Diclofenac Sodium and Misoprostol
| Product NDC: | 0591-0397 |
| Proprietary Name: | Diclofenac Sodium and Misoprostol |
| Non Proprietary Name: | Diclofenac Sodium and Misoprostol |
| Active Ingredient(s): | 50; 200 mg/1; ug/1 & nbsp; Diclofenac Sodium and Misoprostol |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Diclofenac Sodium and Misoprostol
| Product NDC: | 0591-0397 |
| Labeler Name: | Watson Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA201089 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121101 |
Package Information of Diclofenac Sodium and Misoprostol
| Package NDC: | 0591-0397-60 |
| Package Description: | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60) |
NDC Information of Diclofenac Sodium and Misoprostol
| NDC Code | 0591-0397-60 |
| Proprietary Name | Diclofenac Sodium and Misoprostol |
| Package Description | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60) |
| Product NDC | 0591-0397 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Diclofenac Sodium and Misoprostol |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20121101 |
| Marketing Category Name | ANDA |
| Labeler Name | Watson Laboratories, Inc. |
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
| Strength Number | 50; 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] |
