Label: BETAMETHASONE DIPROPIONATE cream
- NDC Code(s): 70771-1380-1, 70771-1380-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 3, 2022
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INGREDIENTS AND APPEARANCE
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE 0.5 mg in 1 g Inactive Ingredients Ingredient Name Strength CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1380-1 1 in 1 CARTON 02/26/2019 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1380-4 1 in 1 CARTON 02/26/2019 2 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208885 02/26/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1380) , MANUFACTURE(70771-1380)
