| Product NDC: | 76519-1007 |
| Proprietary Name: | Nystatin |
| Non Proprietary Name: | Nystatin |
| Active Ingredient(s): | 100000 [USP'U]/g & nbsp; Nystatin |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | POWDER |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 76519-1007 |
| Labeler Name: | H.J. Harkins Company, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA065203 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090915 |
| Package NDC: | 76519-1007-5 |
| Package Description: | 15 g in 1 BOTTLE, PLASTIC (76519-1007-5) |
| NDC Code | 76519-1007-5 |
| Proprietary Name | Nystatin |
| Package Description | 15 g in 1 BOTTLE, PLASTIC (76519-1007-5) |
| Product NDC | 76519-1007 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Nystatin |
| Dosage Form Name | POWDER |
| Route Name | TOPICAL |
| Start Marketing Date | 20090915 |
| Marketing Category Name | ANDA |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | NYSTATIN |
| Strength Number | 100000 |
| Strength Unit | [USP'U]/g |
| Pharmaceutical Classes | Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] |