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].

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 05/17

AV 07/20 (P)

AvPAK

PRINCIPAL DISPLAY PANEL-5 mg

5
(click image for full-size original)

PRINCIPAL DISPLAY PANEL-10 mg

10
(click image for full-size original)

GLIPIZIDE
glipizide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-361(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:50268-361-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-361-11)
1 NDC:50268-361-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-361-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075795 07/10/2020
GLIPIZIDE
glipizide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-362(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:50268-362-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-362-11)
1 NDC:50268-362-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-362-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075795 07/10/2020
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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