Alfuzosin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-956-81
Alfuzosin Hydrochloride Extended-Release Tablets
10 mg
PHARMACIST: Dispense with Patient Information



Rx only
90 Tablets
SUN PHARMA

label
(click image for full-size original)
label
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-956
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
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 956
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-956-83 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:47335-956-81 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:47335-956-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:47335-956-08 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:47335-956-18 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079057 11/22/2011
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-956), MANUFACTURE (47335-956)

Revised: 12/2020 Sun Pharmaceutical Industries, Inc.

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