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 Prefilled Syringe Carton
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 0.6 mg/0.6 mL Autoinjector Carton
(click image for full-size original)
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

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