Kalbitor
These highlights do not include all the information needed to use KALBITOR safely and effectively. See full prescribing information for KALBITOR. KALBITOR (ecallantide) injection, for subcutaneous use Initial U.S. Approval: 2009
Approved
Approval ID
f56aec67-c662-477c-b866-bfc23e8809cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ecallantide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47783-101
Application NumberBLA125277
Product Classification
M
Marketing Category
C73585
G
Generic Name
Ecallantide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 17, 2021
FDA Product Classification
INGREDIENTS (5)
EcallantideActive
Quantity: 10 mg in 1 mL
Code: 5Q6TZN2HNM
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 0.76 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
Monobasic Potassium PhosphateInactive
Quantity: 0.2 mg in 1 mL
Code: 4J9FJ0HL51
Classification: IACT
Sodium ChlorideInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Potassium ChlorideInactive
Quantity: 0.2 mg in 1 mL
Code: 660YQ98I10
Classification: IACT