| Product NDC: | 52959-811 |
| Proprietary Name: | TERCONAZOLE |
| Non Proprietary Name: | terconazole |
| Active Ingredient(s): | 4 mg/g & nbsp; terconazole |
| Administration Route(s): | VAGINAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52959-811 |
| Labeler Name: | H.J. Harkins Company, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019579 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20040401 |
| Package NDC: | 52959-811-03 |
| Package Description: | 45 g in 1 TUBE, WITH APPLICATOR (52959-811-03) |
| NDC Code | 52959-811-03 |
| Proprietary Name | TERCONAZOLE |
| Package Description | 45 g in 1 TUBE, WITH APPLICATOR (52959-811-03) |
| Product NDC | 52959-811 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | terconazole |
| Dosage Form Name | CREAM |
| Route Name | VAGINAL |
| Start Marketing Date | 20040401 |
| Marketing Category Name | NDA |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | TERCONAZOLE |
| Strength Number | 4 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Azole Antifungal [EPC],Azoles [Chemical/Ingredient] |