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
9f6952c8-e547-4f3e-a978-a88d6ea9dc10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DARIFENACIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-223
Application NumberANDA207681
Product Classification
M
Marketing Category
C73584
G
Generic Name
DARIFENACIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2021
FDA Product Classification
INGREDIENTS (8)
DARIFENACIN HYDROBROMIDEActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DARIFENACIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-224
Application NumberANDA207681
Product Classification
M
Marketing Category
C73584
G
Generic Name
DARIFENACIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2021
FDA Product Classification
INGREDIENTS (10)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
DARIFENACIN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT