| Product NDC: | 58980-818 |
| Proprietary Name: | Azolen |
| Non Proprietary Name: | Miconazole Nitrate |
| Active Ingredient(s): | 20 mg/mL & nbsp; Miconazole Nitrate |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | TINCTURE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58980-818 |
| Labeler Name: | Stratus Pharmaceuticals, Inc. |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part333C |
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Start Marketing Date: | 20111201 |
| Package NDC: | 58980-818-10 |
| Package Description: | 1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) > 29.57 mL in 1 BOTTLE, WITH APPLICATOR |
| NDC Code | 58980-818-10 |
| Proprietary Name | Azolen |
| Package Description | 1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) > 29.57 mL in 1 BOTTLE, WITH APPLICATOR |
| Product NDC | 58980-818 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Miconazole Nitrate |
| Dosage Form Name | TINCTURE |
| Route Name | TOPICAL |
| Start Marketing Date | 20111201 |
| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
| Labeler Name | Stratus Pharmaceuticals, Inc. |
| Substance Name | MICONAZOLE NITRATE |
| Strength Number | 20 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |