Label: CLOBETASOL PROPIONATE ointment
- NDC Code(s): 70771-1209-1, 70771-1209-2, 70771-1209-3, 70771-1209-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 4, 2022
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INGREDIENTS AND APPEARANCE
CLOBETASOL PROPIONATE
clobetasol propionate ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1209 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE 0.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1209-1 1 in 1 CARTON 03/22/2018 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1209-2 1 in 1 CARTON 03/22/2018 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70771-1209-4 1 in 1 CARTON 03/22/2018 3 45 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70771-1209-3 1 in 1 CARTON 03/22/2018 4 60 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 ANDA210199 03/22/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650650802) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1209) , MANUFACTURE(70771-1209)
