Glycopyrrolate (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69315-139-01

1 mg: Bottle of 100 Tablets

Glycopyrrolate 1mg 100tabs
(click image for full-size original)

NDC 69315-140-01

2 mg: Bottle of 100 Tablets

Glycopyrrolate 2mg 100tabs
(click image for full-size original)
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-139
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 1 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
ANHYDROUS LACTOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code EP;139
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-139-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090195 09/22/2018
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69315-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
ANHYDROUS LACTOSE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code EP;140
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69315-140-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090195 09/22/2018
Labeler — Leading Pharma, LLC (079575060)
Establishment
Name Address ID/FEI Operations
Leading Pharma, LLC 079575060 MANUFACTURE (69315-139) (69315-140)

Revised: 09/2020 Leading Pharma, LLC

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