Alfuzosin Hydrochloride
These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride. Alfuzosin hydrochloride extended-release tablets, USP for Oral UseInitial U.S. Approval: 2003
Approved
Approval ID
3cc028d5-309f-4ce3-a2d7-5804ab57677d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2020
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-844
Application NumberANDA090284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2020
FDA Product Classification
INGREDIENTS (6)
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT