Darifenacin 7.5 mg
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
7e9f2cec-8c9f-7668-dfb4-6ab57c9d3e8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Xiromed, LLC
DUNS: 080228637
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 Code70700-182
Application NumberANDA209571
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (10)
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Darifenacin HydrobromideActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Hypromellose 2208 (4000 Mpa.S)Inactive
Code: 39J80LT57T
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Darifenacin Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-183
Application NumberANDA209571
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (13)
Darifenacin HydrobromideActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Hypromellose 2208 (4000 Mpa.S)Inactive
Code: 39J80LT57T
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
MaltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT