Solifenacin
Solifenacin Succinate Tablets
Approved
Approval ID
686105dc-03e0-4e11-bb55-52a0460ab262
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Solifenacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1604
Application NumberANDA207721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Solifenacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2022
FDA Product Classification
INGREDIENTS (9)
SOLIFENACIN SUCCINATEActive
Quantity: 5 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Solifenacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1605
Application NumberANDA207721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Solifenacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2022
FDA Product Classification
INGREDIENTS (9)
SOLIFENACIN SUCCINATEActive
Quantity: 10 mg in 1 1
Code: KKA5DLD701
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/26/2020
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1604-3
Solifenacin succinate tablets, 5 mg
Rx only
30 tablets
NDC 70771-1605-3
Solifenacin succinate tablets, 10 mg
Rx only
30 tablets
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/26/2020