Icatibant
These highlights do not include all the information needed to use ICATIBANT INJECTION safely and effectively. See full prescribing information for ICATIBANT INJECTION. ICATIBANT injection, for subcutaneous use Initial U.S. Approval: 2011
Approved
Approval ID
56d5047e-3f99-4100-af4f-388870986ced
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Icatibant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-351
Application NumberANDA213521
Product Classification
M
Marketing Category
C73584
G
Generic Name
Icatibant
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (5)
ICATIBANT ACETATEActive
Quantity: 30 mg in 3 mL
Code: 325O8467XK
Classification: ACTIM
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT