| Product NDC: | 64011-246 |
| Proprietary Name: | gynazole 1 |
| Non Proprietary Name: | Butoconazole Nitrate |
| Active Ingredient(s): | 100 mg/5g & nbsp; Butoconazole Nitrate |
| Administration Route(s): | VAGINAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 64011-246 |
| Labeler Name: | Ther-Rx Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200923 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121227 |
| Package NDC: | 64011-246-01 |
| Package Description: | 1 TUBE in 1 CARTON (64011-246-01) > 5.8 g in 1 TUBE |
| NDC Code | 64011-246-01 |
| Proprietary Name | gynazole 1 |
| Package Description | 1 TUBE in 1 CARTON (64011-246-01) > 5.8 g in 1 TUBE |
| Product NDC | 64011-246 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Butoconazole Nitrate |
| Dosage Form Name | CREAM |
| Route Name | VAGINAL |
| Start Marketing Date | 20121227 |
| Marketing Category Name | ANDA |
| Labeler Name | Ther-Rx Corporation |
| Substance Name | BUTOCONAZOLE NITRATE |
| Strength Number | 100 |
| Strength Unit | mg/5g |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |