Alfuzosin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-306-30

Label
(click image for full-size original)
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-306(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:70934-306-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079057 03/21/2019
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-306)

Revised: 11/2021 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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