Label: NYSTATIN powder
- NDC Code(s): 70771-1585-1, 70771-1585-2, 70771-1585-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
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INGREDIENTS AND APPEARANCE
NYSTATIN
nystatin powderProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1585 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1585-1 15 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/06/2021 2 NDC:70771-1585-3 60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/06/2021 3 NDC:70771-1585-2 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208581 10/06/2021 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(70771-1585) , MANUFACTURE(70771-1585)
