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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 use Initial U.S. Approval: 2021

Approved
Approval ID

c6c32b47-c47c-4a7f-8d4d-23578f663217

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2023

Manufacturers
FDA

Zealand Pharma US, Inc

DUNS: 117052161

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 Code80644-0013
Application NumberNDA214231
Product Classification
M
Marketing Category
C73594
G
Generic Name
dasiglucagon
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 4, 2023
FDA Product Classification

INGREDIENTS (6)

TROMETHAMINEInactive
Quantity: 3.82 mg in 0.6 mL
Code: 023C2WHX2V
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.44 mg in 0.6 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DASIGLUCAGONActive
Quantity: 0.6 mg in 0.6 mL
Code: AD4J2O47FQ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

dasiglucagon

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80644-0012
Application NumberNDA214231
Product Classification
M
Marketing Category
C73594
G
Generic Name
dasiglucagon
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 4, 2023
FDA Product Classification

INGREDIENTS (6)

DASIGLUCAGONActive
Quantity: 0.6 mg in 0.6 mL
Code: AD4J2O47FQ
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.44 mg in 0.6 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Quantity: 3.82 mg in 0.6 mL
Code: 023C2WHX2V
Classification: IACT

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Zegalogue - FDA Drug Approval Details