Label: DAPSONE gel
- NDC Code(s): 70771-1538-2, 70771-1538-3, 70771-1538-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 9, 2024
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INGREDIENTS AND APPEARANCE
DAPSONE
dapsone gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1538 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 75 mg in 1 g Inactive Ingredients Ingredient Name Strength ACRYLAMIDE (UNII: 20R035KLCI) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ISOHEXADECANE (UNII: 918X1OUF1E) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (off white to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1538-2 1 in 1 CARTON 05/10/2024 1 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:70771-1538-3 1 in 1 CARTON 05/10/2024 2 60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:70771-1538-8 1 in 1 CARTON 05/10/2024 3 90 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214019 05/10/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1538) , MANUFACTURE(70771-1538)
