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FDA Drug information

Glycopyrrolate

Read time: 1 mins
Marketing start date: 22 Jul 2024

Summary of product characteristics


Effective Time

20221105

Version

2

Spl Product Data Elements

Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Glycopyrrolate Glycopyrrolate GLYCOPYRROLATE GLYCOPYRRONIUM BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Application Number

ANDA214213

Brand Name

Glycopyrrolate

Generic Name

Glycopyrrolate

Product Ndc

70771-1618

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR,INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1616-1 Glycopyrrolate Injection, USP 0.2 mg/mL NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 1 mL Single-Dose Vial Rx only NDC 70771-1616-7 Glycopyrrolate Injection, USP 0.2 mg/mL NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 1 mL Single-Dose Vials Rx only NDC 70771-1617-1 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 2 mL Single-Dose Vial Rx only NDC 70771-1617-7 Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 2 mL Single-Dose Vials Rx only NDC 70771-1618-1 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 5 mL Multiple-Dose Vial Rx only NDC 70771-1618-7 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 25 x 5 mL Multiple-Dose Vials Rx only NDC 70771-1619-1 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 20 mL Multiple-Dose Vial Rx only NDC 70771-1619-6 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) NOT FOR USE IN NEWBORNS CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION 10 x 20 mL Multiple-Dose Vials Rx only 1 mL vial carton of 25 of 1 mL vial 2 mL vial carton of 2 mL 25 vials 5 mL vial carton of 25 of 5 mL vial 20 mL vial carton of 10 - 20 mL vials

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