GLYCOPYRROLATE- glycopyrrolate injection 
Zydus Lifesciences Limited

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Glycopyrrolate Injection, USP

Rx only
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL

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

1 mL vial

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

carton of 25 of 1 mL vial

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

2 mL vial

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

carton of 2 mL 25 vials

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

5 mL vial

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

carton of 25 of 5 mL vial

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

20 mL vial

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

carton of 10 - 20 mL vials
GLYCOPYRROLATE 
glycopyrrolate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1616
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1616-625 in 1 CARTON11/18/202103/25/2025
1NDC:70771-1616-11 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21421311/18/202106/03/2025
GLYCOPYRROLATE 
glycopyrrolate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1617
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1617-72 mL in 1 VIAL; Type 0: Not a Combination Product11/18/202103/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21421311/18/202106/03/2025
GLYCOPYRROLATE 
glycopyrrolate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1618
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1618-725 in 1 CARTON11/18/202103/25/2025
1NDC:70771-1618-15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21421311/18/202106/03/2025
GLYCOPYRROLATE 
glycopyrrolate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1619
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1619-610 in 1 CARTON11/18/202103/25/2025
1NDC:70771-1619-120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21421311/18/202106/03/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1616, 70771-1617, 70771-1618, 70771-1619) , ANALYSIS(70771-1616, 70771-1617, 70771-1618, 70771-1619)

Revised: 6/2025
Document Id: cb2e73f7-3634-44bc-9e83-f8f9a84a6ac3
Set id: 8374b0c5-aa94-4103-b074-10c57219b677
Version: 3
Effective Time: 20250603
 
Zydus Lifesciences Limited