Glycopyrrolate (Page 4 of 4)

NDC 16714-536-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2 mg/1 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
1 mL Single Dose Vial Rx Only

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NDC 16714-536-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2mg/1 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 1 mL Single Dose Vials
Rx Only

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NDC 16714-620-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
2 mL Single Dose Vial Rx Only

//medlibrary.org/lib/images-rx/glycopyrrolate-17/2-ml-vial-label-300x99.jpg
(click image for full-size original)

NDC 16714-620-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 2 mL Single Dose Vials Rx Only

//medlibrary.org/lib/images-rx/glycopyrrolate-17/2-ml-carton-label-300x177.jpg
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GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-536
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
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-536-25 25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-25)
2 NDC:16714-536-01 1 VIAL in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 08/10/2022
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-620
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
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-620-25 25 VIAL in 1 CARTON contains a VIAL
1 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-25)
2 NDC:16714-620-01 1 VIAL in 1 CARTON contains a VIAL
2 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 11/18/2022
Labeler — NORTHSTAR RX LLC (830546433)
Registrant — Apotex Inc. (209429182)

Revised: 11/2022 NORTHSTAR RX LLC

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