Alfuzosin Hydrochloride
These highlights do not include all the information needed to use ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. ALFUZOSIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
80f6ec1b-b04e-4660-814c-50b46136dcb0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alfuzosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2353
Application NumberANDA079057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2023
FDA Product Classification
INGREDIENTS (8)
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT