NDC Code(s) : 57237-114-90, 57237-114-01, 57237-114-05
Packager : Rising Pharma Holdings, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-114
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 8 mm
Flavor Imprint Code X;23
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-114-9090 in 1 BOTTLE Type 0: Not a Combination Product30/08/2012
2NDC:57237-114-01100 in 1 BOTTLE Type 0: Not a Combination Product30/08/2012
3NDC:57237-114-05500 in 1 BOTTLE Type 0: Not a Combination Product30/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079060 08/30/2012

LABELER - Rising Pharma Holdings, Inc.(116880195)

REGISTRANT - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917642 ANALYSIS(57237-114), MANUFACTURE(57237-114)

PRINCIPAL DISPLAY PANEL


Rising®                 NDC 57237-114-90
Alfuzosin
Hydrochloride
 Extended-Release
T ablets USP 
10 mg
90 Tablets             Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Bottle)