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
ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-664
Application NumberANDA212446
Product Classification
M
Marketing Category
C73584
G
Generic Name
ICATIBANT
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (5)
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
SODIUM HYDROXIDEInactive
Quantity: 1.92 mg in 3 mL
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT