Glycopyrrolate (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 70710-1646 -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

Zydus Pharmaceuticals Logo

vial-2ml
(click image for full-size original)

NDC 70710-1646 -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

Zydus Pharmaceuticals

carton-2ml
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70710-1647 -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

Zydus Pharmaceuticals Logo

vial-5ml
(click image for full-size original)

NDC 70710-1647 -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

Zydus Pharmaceuticals

carton-5ml
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70710-1648 -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

Zydus Pharmaceuticals Logo

vial-20 ml
(click image for full-size original)

NDC 70710-1648-6

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

Zydus Pharmaceuticals

carton-20ml
(click image for full-size original)
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1645
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 Multilevel Packaging
1 NDC:70710-1645-7 25 VIAL in 1 CARTON contains a VIAL (70710-1645-1)
1 NDC:70710-1645-1 1 mL in 1 VIAL This package is contained within the CARTON (70710-1645-7)
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 Item Code (Source) NDC:70710-1646
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 Multilevel Packaging
1 NDC:70710-1646-7 25 VIAL in 1 CARTON contains a VIAL (70710-1646-1)
1 NDC:70710-1646-1 2 mL in 1 VIAL This package is contained within the CARTON (70710-1646-7)
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 Item Code (Source) NDC:70710-1647
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 Multilevel Packaging
1 NDC:70710-1647-7 25 VIAL in 1 CARTON contains a VIAL (70710-1647-1)
1 NDC:70710-1647-1 5 mL in 1 VIAL This package is contained within the CARTON (70710-1647-7)
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 Item Code (Source) NDC:70710-1648
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 Multilevel Packaging
1 NDC:70710-1648-6 10 VIAL in 1 CARTON contains a VIAL (70710-1648-1)
1 NDC:70710-1648-1 20 mL in 1 VIAL This package is contained within the CARTON (70710-1648-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214213 11/18/2021
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 873671928 MANUFACTURE (70710-1645), MANUFACTURE (70710-1646), MANUFACTURE (70710-1647), MANUFACTURE (70710-1648), ANALYSIS (70710-1645), ANALYSIS (70710-1646), ANALYSIS (70710-1647), ANALYSIS (70710-1648)

Revised: 11/2020 Zydus Pharmaceuticals (USA) Inc.

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