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:

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

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