Uroxatral
These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003
Approved
Approval ID
9fc7f119-f36b-44cf-945d-940160f3afe3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2021
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alfuzosin HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-200
Application NumberNDA021287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Alfuzosin HCl
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (10)
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
alfuzosin hydrochlorideActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ethylcellulose (100 mpa.s)Inactive
Code: 47MLB0F1MV
Classification: IACT
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT