Label: DICLOFENAC SODIUM liquid
- NDC Code(s): 70771-1415-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2023
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INGREDIENTS AND APPEARANCE
DICLOFENAC SODIUM
diclofenac sodium liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 16.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1415-9 1 in 1 CARTON 08/08/2018 1 150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206411 08/08/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650650802) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1415) , MANUFACTURE(70771-1415)
