Unituxin
These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN (dinutuximab) injection, for intravenous use Initial U.S. Approval: 2015
Approved
Approval ID
d66bdf0d-9d65-45de-ae5b-a58617c27492
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
United Therapeutics Corporation
DUNS: 965460025
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DINUTUXIMAB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66302-014
Application NumberBLA125516
Product Classification
M
Marketing Category
C73585
G
Generic Name
DINUTUXIMAB
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (6)
histidineInactive
Code: 4QD397987E
Classification: IACT
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
DINUTUXIMABActive
Quantity: 3.5 mg in 1 mL
Code: 7SQY4ZUD30
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT