Alfuzosin hydrochloride
These highlights do not include all the information needed to use ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLET 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
644295a9-75cb-4326-a71f-b0f4e0c4cf75
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2022
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-155
Application NumberANDA203192
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2022
FDA Product Classification
INGREDIENTS (7)
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT