NDC 66302-014

Unituxin

Dinutuximab

Unituxin is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by United Therapeutics Corp.. The primary component is Dinutuximab.

• Product ID: 66302-014_1fa6e0b3-94f3-4927-84f4-0be125baa1f0
• NDC: 66302-014
• Product Type: Human Prescription Drug
• Proprietary Name: Unituxin
• Generic Name: Dinutuximab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-03-10
• Marketing Category: BLA / BLA
• Application Number: BLA125516
• Labeler Name: United Therapeutics Corp.
• Substance Name: DINUTUXIMAB
• Active Ingredient Strength: 4 mg/mL
• Pharm Classes: Glycolipid Disialoganglioside-directed Antibody [EPC],Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66302-014-01

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

• Marketing Start Date: 2015-03-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66302-014-01 [66302001401]

Unituxin INJECTION

• Marketing Category: BLA
• Application Number: BLA125516
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-10

Drug Details

Active Ingredients

Ingredient	Strength
DINUTUXIMAB	3.5 mg/mL

OpenFDA Data

• SPL SET ID: d66bdf0d-9d65-45de-ae5b-a58617c27492
• Manufacturer:
  • United Therapeutics Corp.
• UNII:
  • 7SQY4ZUD30
• RxNorm Concept Unique ID - RxCUI:
  • 1606278
  • 1606283

Pharmacological Class

• Glycolipid Disialoganglioside-directed Antibody [EPC]
• Glycolipid Disialoganglioside-directed Antibody Interactions [MoA]