Label: CLINDAMYCIN PHOSPHATE gel
- NDC Code(s): 70771-1855-2, 70771-1855-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2023
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INGREDIENTS AND APPEARANCE
CLINDAMYCIN PHOSPHATE
clindamycin phosphate gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1855 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1855-2 1 in 1 CARTON 09/20/2023 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771-1855-3 1 in 1 CARTON 09/20/2023 2 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 ANDA216587 09/20/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1855) , MANUFACTURE(70771-1855)
