Label: FESOTERODINE FUMARATE tablet, film coated, extended release
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NDC Code(s):
70771-1168-2,
70771-1168-3,
70771-1168-4,
70771-1168-9, view more70771-1169-2, 70771-1169-3, 70771-1169-4, 70771-1169-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated August 26, 2022
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FESOTERODINE FUMARATE
fesoterodine fumarate tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1168 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE 4 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color YELLOW (Light Yellow) Score no score Shape OVAL (Oval) Size 13mm Flavor Imprint Code 479 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1168-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/07/2017 2 NDC:70771-1168-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/07/2017 3 NDC:70771-1168-4 10 in 1 CARTON 12/07/2017 3 NDC:70771-1168-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204946 12/07/2017 FESOTERODINE FUMARATE
fesoterodine fumarate tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1169 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE 8 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (White to Off-White) Score no score Shape OVAL (Oval) Size 13mm Flavor Imprint Code 480 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1169-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/07/2017 2 NDC:70771-1169-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/07/2017 3 NDC:70771-1169-4 10 in 1 CARTON 12/07/2017 3 NDC:70771-1169-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204946 12/07/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1168, 70771-1169) , MANUFACTURE(70771-1168, 70771-1169)
