Glycopyrrolate

Basic Information

Product Name

Glycopyrrolate

FDA Product Code

71872-7307

Regulatory Information

NDC Product Code

71872-7307

Application Number

ANDA212612

Marketing Category

C73584

Effective Date

November 2, 2023

Territorial Authority

USA

FDA Title

GLYCOPYRROLATE injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZYL ALCOHOL

Quantity: 9 mg in 1 mL

Code: LKG8494WBH

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

GLYCOPYRROLATE

Quantity: 0.2 mg in 1 mL

Code: V92SO9WP2I

Class Code: ACTIB

Active Moieties

GLYCOPYRRONIUM

Code: A14FB57V1D

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

BENZYL ALCOHOL

HYDROCHLORIC ACID

SODIUM HYDROXIDE

Active Moieties

GLYCOPYRRONIUM