FDA Product

Glycopyrrolate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Glycopyrrolate

FDA Product Code

0143-9585

Regulatory Information

NDC Product Code

0143-9585

Application Number

ANDA090963

Marketing Category

C73584

Effective Date

March 4, 2022

Territorial Authority

USA

FDA Title

GLYCOPYRROLATE INJECTION, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

10

Company Information

ManufacturerHikma Pharmaceuticals USA Inc.

DUNS Number

001230762

Active Ingredients

Quantity: 0.2 mg in 1 mL

Code: V92SO9WP2I

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZYL ALCOHOL

Quantity: 9 mg in 1 mL

Code: LKG8494WBH

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

GLYCOPYRRONIUM

Code: A14FB57V1D

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