NDC Code(s) : 24987-200-10, 24987-200-20
Packager : Covis Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Uroxatralalfuzosin HCl TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24987-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alfuzosin hydrochloride(UNII: 75046A1XTN)
(alfuzosin - UNII:90347YTW5F) 		alfuzosin hydrochloride10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
ethylcellulose (100 mpa.s)(UNII: 47MLB0F1MV)
hydrogenated castor oil(UNII: ZF94AP8MEY)
hypromelloses(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
mannitol(UNII: 3OWL53L36A)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
ferric oxide yellow(UNII: EX438O2MRT)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code X10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24987-200-10100 in 1 BOTTLE Type 0: Not a Combination Product03/06/2013
2NDC:24987-200-20100 in 1 BOTTLE Type 0: Not a Combination Product03/06/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021287 06/03/2013 04/30/2016

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Label

NDC 24987-200-10 X-010

Uroxatral ®
alfuzosin HCl 10 mg
Extended-Release Tablets

1 Bottle Rx only
100 Tablets

Keep out of reach of children

Covis

Mfd. for:
Covis Pharmaceuticals, Inc.
Cary, NC 27511 ©2013
Origin France
100113 Rev. 4/13 50106150

See package insert for dosage information.
Protect from light and moisture.
Dispense in a tight, light-resistant
container as described in the USP.
Store at 25°C (77°F); excursions permitted
to 15-30°C (59-86°F) [see USP Controlled
Room Temperature].

Uroxatral LabelBottle Label