NDC Code(s) : 63629-7907-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alfuzosin hydrochlorideAlfuzosin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-7907(NDC:29300-155)
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
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code U;155
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-7907-190 in 1 BOTTLE Type 0: Not a Combination Product02/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203192 03/15/2016

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-7907), RELABEL(63629-7907)

PRINCIPAL DISPLAY PANEL

ALFUZOSIN HCL ER 10MG TABLET

Label