Darifenacin
These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
62a72d3e-3c33-4f2d-b3d0-2e014f704c63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2022
Manufacturers
FDA
POLYGEN PHARMACEUTICALS INC.
DUNS: 962415720
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Darifenacin Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52605-067
Application NumberANDA211045
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2022
FDA Product Classification
INGREDIENTS (7)
DARIFENACIN HYDROBROMIDEActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Darifenacin Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52605-068
Application NumberANDA211045
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2022
FDA Product Classification
INGREDIENTS (9)
DARIFENACIN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT