Prescription Drug Information: Zegalogue (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 0.6 mg/0.6 mL Prefilled Syringe Carton

Emergency Use for Very Low Blood Sugar

ZEGALOGUE ^®
(dasiglucagon) injection
0.6 mg/0.6 mL*
Prefilled Syringe

Single-Dose

Injection, for subcutaneous use. Rx only
NDC 80644-0013-1

Carton contents:
1 Single-Dose Prefilled Syringe 1 Prescribing Information

OPEN HERE

ZEALAND PHARMA

PRINCIPAL DISPLAY PANEL — 0.6 mg/0.6 mL Autoinjector Carton

Emergency Use for Very Low Blood Sugar

ZEGALOGUE ^®
(dasiglucagon) injection
0.6 mg/0.6 mL*
Autoinjector

Single-Dose

Injection, for subcutaneous use. Rx only
NDC 80644-0012-1

Carton contents:
1 Single-Dose Autoinjector 1 Prescribng Information

OPEN HERE

ZEALAND PHARMA

ZEGALOGUE dasiglucagon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80644-0013 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASIGLUCAGON (DASIGLUCAGON) DASIGLUCAGON 0.6 mg in 0.6 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE 3.82 mg in 0.6 mL SODIUM CHLORIDE 6.44 mg in 0.6 mL WATER HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80644-0013-1 1 CONTAINER in 1 PACKAGE contains a CONTAINER 1 1 SYRINGE, GLASS in 1 CONTAINER This package is contained within the PACKAGE (80644-0013-1) and contains a SYRINGE, GLASS 1 0.6 mL in 1 SYRINGE, GLASS This package is contained within a CONTAINER and a PACKAGE (80644-0013-1) 2 NDC:80644-0013-2 2 PACKAGE in 1 CARTON contains a PACKAGE 2 1 CONTAINER in 1 PACKAGE This package is contained within the CARTON (80644-0013-2) and contains a CONTAINER 2 1 SYRINGE, GLASS in 1 CONTAINER This package is contained within the PACKAGE and contains a SYRINGE, GLASS 2 0.6 mL in 1 SYRINGE, GLASS This package is contained within a CONTAINER and a PACKAGE and a CARTON (80644-0013-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA214231 04/05/2021

ZEGALOGUE dasiglucagon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80644-0012 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASIGLUCAGON (DASIGLUCAGON) DASIGLUCAGON 0.6 mg in 0.6 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE 3.82 mg in 0.6 mL SODIUM CHLORIDE 6.44 mg in 0.6 mL WATER HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80644-0012-1 1 CONTAINER in 1 PACKAGE contains a CONTAINER 1 1 SYRINGE, GLASS in 1 CONTAINER This package is contained within the PACKAGE (80644-0012-1) and contains a SYRINGE, GLASS 1 0.6 mL in 1 SYRINGE, GLASS This package is contained within a CONTAINER and a PACKAGE (80644-0012-1) 2 NDC:80644-0012-2 2 PACKAGE in 1 CARTON contains a PACKAGE 2 1 CONTAINER in 1 PACKAGE This package is contained within the CARTON (80644-0012-2) and contains a CONTAINER 2 1 SYRINGE, GLASS in 1 CONTAINER This package is contained within the PACKAGE and contains a SYRINGE, GLASS 2 0.6 mL in 1 SYRINGE, GLASS This package is contained within a CONTAINER and a PACKAGE and a CARTON (80644-0012-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA214231 04/05/2021

Labeler — Zealand Pharma A/S (586358020)

Revised: 04/2021 Zealand Pharma A/S