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 C19H28BrNO3, 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

GLYCOPYRROLATE
glycopyrrolate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43227-065
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)	GLYCOPYRROLATE	1 mg

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONES (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	K;400
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43227-065-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)	GLYCOPYRROLATE	2 mg

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONES (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	K;401
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43227-066-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040653	09/26/2006

Labeler - Par Formulations Private Limited (676159161)

Registrant - Par Formulations Private Limited (676159161)

Glycopyrrolate Tablets USP

DESCRIPTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL