Glipizide (Page 4 of 4)

RECOMMENDED STORAGE

Store at 20˚C to 25˚C (68˚F to 77˚F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container [see USP].

APOTEX INC.
GLIPIZIDE TABLETS, USP
5 mg and 10 mg

Manufactured by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 USA 33326

Revised: May 2017

Rev. 8

PRINCIPAL DISPLAY PANEL-10 mg

NDC: 70934-746-30

Label
(click image for full-size original)
GLIPIZIDE
glipizide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-862(NDC:60505-0142)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code APO;GLP;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-862-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075795 06/07/2021
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 (70934-862)

Revised: 06/2021 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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