Glycopyrrolate

GLYCOPYRROLATE — glycopyrrolate tablet
Par Formulations Private Limited

DESCRIPTION

Glycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-

dimethylpyrrolidinium bromide. Its empirical formula is C19 H28 BrNO3 , its molecular weight is 398.33, and its structural formula is:

glycopyrrolate
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Each 1 mg tablet contains: Glycopyrrolate, USP …………….1 mg

Each 2 mg tablet contains: Glycopyrrolate, USP …………….2 mg

Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

glycopyrrolate
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glycopyrrolate
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glycopyrrolateglycopyrrolate
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43227-065
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code K;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43227-065-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040653 09/26/2006
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43227-066
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code K;401
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43227-066-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040653 09/26/2006
Labeler — Par Formulations Private Limited (676159161)
Registrant — Par Formulations Private Limited (676159161)

Revised: 07/2016 Par Formulations Private Limited

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