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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

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Unituxin - FDA Drug Approval Details