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
e2aa9544-0136-463d-a73b-1a299534446a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2021
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 835513529
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 Code16571-768
Application NumberANDA206743
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2021
FDA Product Classification
INGREDIENTS (15)
DARIFENACIN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Darifenacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16571-767
Application NumberANDA206743
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2021
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
DARIFENACIN HYDROBROMIDEActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT