Label: SOLIFENACIN tablet, film coated
- NDC Code(s): 70771-1604-3, 70771-1604-9, 70771-1605-3, 70771-1605-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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INGREDIENTS AND APPEARANCE
SOLIFENACIN
solifenacin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1604 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE 5 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (BICONVEX) Size 8mm Flavor Imprint Code 987 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1604-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2022 2 NDC:70771-1604-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207721 02/10/2022 SOLIFENACIN
solifenacin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1605 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color WHITE (LIGHT PINK) Score no score Shape ROUND (BICONVEX) Size 8mm Flavor Imprint Code 988 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1605-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2022 2 NDC:70771-1605-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207721 02/10/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1604, 70771-1605) , MANUFACTURE(70771-1604, 70771-1605)
