Uroxatral (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Label

NDC 0024-4200-10
X-010

Uroxatral ®
alfuzosin HCl 10 mg
Extended-Release Tablets

1 Bottle100 Tablets

Keep out of reach of children

Rx only

sanofi aventis

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Label
(click image for full-size original)
UROXATRAL alfuzosin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-4200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alfuzosin hydrochloride (alfuzosin) alfuzosin hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
ethylcellulose (100 mpa.s)
hydrogenated castor oil
hypromelloses
magnesium stearate
mannitol
cellulose, microcrystalline
povidones
ferric oxide yellow
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code X10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-4200-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0024-4200-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021287 06/05/2009
Labeler — sanofi-aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Sanofi Winthrop Industrie 571879985 MANUFACTURE (0024-4200), ANALYSIS (0024-4200), LABEL (0024-4200), PACK (0024-4200)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis U.S. LLC 011330557 LABEL (0024-4200), PACK (0024-4200)

Revised: 08/2012 sanofi-aventis U.S. LLC

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