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-5 mg

Representative sample of labeling (see HOW SUPPLIEDsection for complete listing)

NDC 68645-574-54

Glipizide Tablets, USP

5 mg

Rx

30 bottle count

PRINCIPAL DISPLAY PANEL-10 mg

Representative sample of labeling (see HOW SUPPLIEDsection for complete listing)

NDC 68645-575-59

Glipizide Tablets, USP

10 mg

Rx

60 bottle count

GLIPIZIDE glipizide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-574(NDC:60505-0141) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 5 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 6mm Flavor Imprint Code APO;GLP;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68645-574-54 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075795 09/25/2002

GLIPIZIDE glipizide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-575(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:68645-575-59 60 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075795 09/25/2002

Labeler — Legacy Pharmaceutical Packaging, LLC (143213275)

Revised: 12/2020 Legacy Pharmaceutical Packaging, LLC