Zegalogue
These highlights do not include all the information needed to use ZEGALOGUE safely and effectively. See full prescribing information for ZEGALOGUE.ZEGALOGUE (dasiglucagon) injection, for subcutaneous useInitial U.S. Approval: 2021
Approved
Approval ID
14704879-872c-4967-8779-04a3bbdfb4e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dasiglucagon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-1913
Application NumberNDA214231
Product Classification
M
Marketing Category
C73594
G
Generic Name
dasiglucagon
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
TROMETHAMINEInactive
Quantity: 3.82 mg in 0.6 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.44 mg in 0.6 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DASIGLUCAGONActive
Quantity: 0.6 mg in 0.6 mL
Code: AD4J2O47FQ
Classification: ACTIB
dasiglucagon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-1912
Application NumberNDA214231
Product Classification
M
Marketing Category
C73594
G
Generic Name
dasiglucagon
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 6.44 mg in 0.6 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Quantity: 3.82 mg in 0.6 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DASIGLUCAGONActive
Quantity: 0.6 mg in 0.6 mL
Code: AD4J2O47FQ
Classification: ACTIB