SOLIFENACIN - solifenacin tablet, film coated 
Zydus Lifesciences Limited

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Solifenacin Succinate Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1604-3

Solifenacin succinate tablets, 5 mg

Rx only

30 tablets

5 mg

NDC 70771-1605-3

Solifenacin succinate tablets, 10 mg

Rx only

30 tablets

10 mg
SOLIFENACIN 
solifenacin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1604
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (BICONVEX) Size8mm
FlavorImprint Code 987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1604-330 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
2NDC:70771-1604-990 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20772102/10/2022
SOLIFENACIN 
solifenacin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1605
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (LIGHT PINK) Scoreno score
ShapeROUND (BICONVEX) Size8mm
FlavorImprint Code 988
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1605-990 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
2NDC:70771-1605-330 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20772102/10/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1604, 70771-1605) , MANUFACTURE(70771-1604, 70771-1605)

Revised: 10/2022
Document Id: 205b6c54-6d0b-4c07-b4b8-7a95e9456282
Set id: 686105dc-03e0-4e11-bb55-52a0460ab262
Version: 2
Effective Time: 20221017
 
Zydus Lifesciences Limited