unituxin

Generic: dinutuximab

Labeler: united therapeutics corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name unituxin
Generic Name dinutuximab
Labeler united therapeutics corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dinutuximab 3.5 mg/mL

Manufacturer
United Therapeutics Corporation

Identifiers & Regulatory

Product NDC 66302-014
Product ID 66302-014_b841106b-07b0-473b-9da9-a91b4363e3b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125516
Listing Expiration 2026-12-31
Marketing Start 2015-03-10

Pharmacologic Class

Established (EPC)
glycolipid disialoganglioside-directed antibody [epc]
Mechanism of Action
glycolipid disialoganglioside-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66302014
Hyphenated Format 66302-014

Supplemental Identifiers

RxCUI
1606278 1606283
UNII
7SQY4ZUD30
NUI
N0000191500 N0000191499

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name unituxin (source: ndc)
Generic Name dinutuximab (source: ndc)
Application Number BLA125516 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

66302-014-01 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

dinutuximab (3.5 mg/mL)

Linked Drug Pages (1)

Unituxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b841106b-07b0-473b-9da9-a91b4363e3b4", "openfda": {"nui": ["N0000191500", "N0000191499"], "unii": ["7SQY4ZUD30"], "rxcui": ["1606278", "1606283"], "spl_set_id": ["d66bdf0d-9d65-45de-ae5b-a58617c27492"], "pharm_class_epc": ["Glycolipid Disialoganglioside-directed Antibody [EPC]"], "pharm_class_moa": ["Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]"], "manufacturer_name": ["United Therapeutics Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66302-014-01", "marketing_start_date": "20150310"}], "brand_name": "Unituxin", "product_id": "66302-014_b841106b-07b0-473b-9da9-a91b4363e3b4", "dosage_form": "INJECTION", "pharm_class": ["Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]", "Glycolipid Disialoganglioside-directed Antibody [EPC]"], "product_ndc": "66302-014", "generic_name": "DINUTUXIMAB", "labeler_name": "United Therapeutics Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Unituxin", "active_ingredients": [{"name": "DINUTUXIMAB", "strength": "3.5 mg/mL"}], "application_number": "BLA125516", "marketing_category": "BLA", "marketing_start_date": "20150310", "listing_expiration_date": "20261231"}