Home NDC 66302-014 Unituxin
Product NDC 66302-014
11-digit product format 663020014
Labeler code 66302
Product ID 66302-014_b841106b-07b0-473b-9da9-a91b4363e3b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DINUTUXIMAB
Dosage form INJECTION
Route INTRAVENOUS
Labeler United Therapeutics Corporation
Application BLA125516
Marketing category BLA
Marketing start 2015-03-10
Substance DINUTUXIMAB
Active strength 3.5 mg/mL
Pharmacologic classes Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Unituxin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DINUTUXIMAB 3.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SQY4ZUD30 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1606278 Internal RxNorm lookup 1606283 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-01-30 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 2024-01-30 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 2024-01-30 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 2020-09-03 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 2020-09-03 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 2020-09-03 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 2020-07-22 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 2020-07-22 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 2020-07-22 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
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66302-014-01 Unituxin 1 in 1 BOX INJECTION 1 13 66302-014-01 Unituxin 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66302-014 UNITUXIN (DINUTUXIMAB) INJECTION [UNITED THERAPEUTICS CORPORATION] 11 Current NDC, Legacy NDC, 2 package rows 20241222_d66bdf0d-9d65-45de-ae5b-a58617c27492.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Unituxin DINUTUXIMAB United Therapeutics Corporation d66bdf0d-9d65-45de-ae5b-a58617c27492 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125516 ndc (product): 66302-014
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125516 Unituxin dinutuximab 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 66302-014-01 66302001401 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2015-03-10 0000-00-00 No No Current