FESOTERODINE FUMARATE- fesoterodine fumarate tablet, film coated, extended release 
Zydus Lifesciences Limited

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FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1168-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 4 mg

Rx only

90 tablets

Fesoterodine ER Tablets, 4 mg

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

Fesoterodine ER Tablets, 8 mg
FESOTERODINE FUMARATE 
fesoterodine fumarate tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1168
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE4 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Light Yellow) Scoreno score
ShapeOVAL (Oval) Size13mm
FlavorImprint Code 479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1168-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
2NDC:70771-1168-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
3NDC:70771-1168-410 in 1 CARTON12/07/2017
3NDC:70771-1168-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20494612/07/2017
FESOTERODINE FUMARATE 
fesoterodine fumarate tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE8 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (White to Off-White) Scoreno score
ShapeOVAL (Oval) Size13mm
FlavorImprint Code 480
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1169-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
2NDC:70771-1169-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
3NDC:70771-1169-410 in 1 CARTON12/07/2017
3NDC:70771-1169-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20494612/07/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1168, 70771-1169) , MANUFACTURE(70771-1168, 70771-1169)

Revised: 11/2024
Document Id: 5b9a792a-f173-43f9-917a-af99185196e1
Set id: 26e8cc63-1e1d-4a77-8f53-4c38bcf0d443
Version: 5
Effective Time: 20241130
 
Zydus Lifesciences Limited