Label: KETOCONAZOLE shampoo
- NDC Code(s): 70771-1874-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 12, 2025
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INGREDIENTS AND APPEARANCE
KETOCONAZOLE
ketoconazole shampooProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1874 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROCHLORIC ACID (UNII: QTT17582CB) IMIDUREA (UNII: M629807ATL) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1874-7 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/08/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218559 03/08/2025 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1874) , MANUFACTURE(70771-1874)
