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 useInitial U.S. Approval: 2004
Approved
Approval ID
6e8470d1-c3e6-4644-b70a-aa47ddf79676
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2021
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-432
Application NumberANDA207664
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (9)
DARIFENACIN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Darifenacin Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-431
Application NumberANDA207664
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (7)
DARIFENACIN HYDROBROMIDEActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT