GlucaGen HypoKit (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0169-7065-15

GlucaGen ® HypoKit

(glucagon) for injection

Emergency Use for Low Blood Sugar

1 mg per vial

Single use only. Discard unused portion.

Protect from light

Rx only

Novo Nordisk Inc.

Plainsboro, NJ 08536

www.novonordisk-us.com

1-800-727-6500

Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

HypoKit Carton Sticker
(click image for full-size original)
GLUCAGEN HYPOKIT
glucagon hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7065
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-7065-15 1 KIT in 1 KIT None
2 NDC:0169-7065-21 2 KIT in 1 PACKAGE contains a KIT (0169-7065-15)
2 NDC:0169-7065-15 1 KIT in 1 KIT This package is contained within the PACKAGE (0169-7065-21)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 1 mL
Part 2 1 SYRINGE, GLASS 1 mL
Part 1 of 2
GLUCAGEN
glucagon hydrochloride injection, powder, for solution
Product Information
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLUCAGON HYDROCHLORIDE (GLUCAGON) GLUCAGON 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE 107 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020918 06/22/2005
Part 2 of 2
WATER
water liquid
Product Information
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 SYRINGE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020918 06/22/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020918 06/22/2005
Labeler — Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 306711800 MANUFACTURE (0169-7065), API MANUFACTURE (0169-7065)
Establishment
Name Address ID/FEI Operations
Catalent Belgium SA 370696762 ANALYSIS (0169-7065), MANUFACTURE (0169-7065)

Revised: 03/2021 Novo Nordisk

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