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.
Approved
Approval ID
8a677905-e66d-44f7-b564-6c561387ed03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2016
Manufacturers
FDA
Liberty Pharmaceuticals, Inc.
DUNS: 012568840
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 Code0440-5000
Application NumberANDA090284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2016
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT