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Glycopyrrolate Injection

Package insert / prescribing information
Dosage form: injection
Drug classes: Anticholinergic bronchodilators, Anticholinergics / antispasmodics

Medically reviewed by Drugs.com. Last updated on Nov 1, 2022.

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

GLYCOPYRROLATE
Glycopyrrolate Injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1616
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:70771-1616-6 25 VIAL in 1 CARTON
1 NDC:70771-1616-1 1 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214213 11/18/2021
GLYCOPYRROLATE
Glycopyrrolate Injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1617
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:70771-1617-7 2 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214213 11/18/2021
GLYCOPYRROLATE
Glycopyrrolate Injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1618
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:70771-1618-7 25 VIAL in 1 CARTON
1 NDC:70771-1618-1 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214213 11/18/2021
GLYCOPYRROLATE
Glycopyrrolate Injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1619
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description
1 NDC:70771-1619-6 10 VIAL in 1 CARTON
1 NDC:70771-1619-1 20 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214213 11/18/2021
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1616, 70771-1617, 70771-1618, 70771-1619), ANALYSIS(70771-1616, 70771-1617, 70771-1618, 70771-1619)
Zydus Lifesciences Limited