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
94a53361-4eda-4e30-a153-44cd142983dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 118707839
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 Code24201-207
Application NumberANDA211021
Product Classification
M
Marketing Category
C73584
G
Generic Name
icatibant
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Quantity: 1.92 mg in 3 mL
Code: 55X04QC32I
Classification: IACT
ACETIC ACIDInactive
Quantity: 3.96 mg in 3 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 22.35 mg in 3 mL
Code: 451W47IQ8X
Classification: IACT
ICATIBANT ACETATEActive
Quantity: 30 mg in 3 mL
Code: 325O8467XK
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT