Label: IBUPROFEN AND FAMOTIDINE tablet
- NDC Code(s): 70771-1924-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 28, 2025
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INGREDIENTS AND APPEARANCE
IBUPROFEN AND FAMOTIDINE
ibuprofen and famotidine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1924 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 800 mg FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 26.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to off-white) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 777 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1924-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218684 06/01/2025 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650199482) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1924) , MANUFACTURE(70771-1924)
