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FDA Approval

Zegalogue

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Novo Nordisk
DUNS: 622920320
Effective Date
January 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dasiglucagon(0.6 mg in 0.6 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zegalogue

Product Details

NDC Product Code
0169-1913
Application Number
NDA214231
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
January 1, 2023
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 3.82 mg in 0.6 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.44 mg in 0.6 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: AD4J2O47FQClass: ACTIBQuantity: 0.6 mg in 0.6 mL

Zegalogue

Product Details

NDC Product Code
0169-1912
Application Number
NDA214231
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
January 1, 2023
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.44 mg in 0.6 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 3.82 mg in 0.6 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: AD4J2O47FQClass: ACTIBQuantity: 0.6 mg in 0.6 mL
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