NDC 72187-0401

Elzonris

Tagraxofusp

Elzonris is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Stemline Therapeutics, Inc.. The primary component is Tagraxofusp.

• Product ID: 72187-0401_06e48d75-62c1-4345-96c4-9b3e9d1c03f8
• NDC: 72187-0401
• Product Type: Human Prescription Drug
• Proprietary Name: Elzonris
• Generic Name: Tagraxofusp
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-01-18
• Marketing Category: BLA / BLA
• Application Number: BLA761116
• Labeler Name: Stemline Therapeutics, Inc.
• Substance Name: TAGRAXOFUSP
• Active Ingredient Strength: 1000 ug/mL
• Pharm Classes: CD123 Interaction [EPC], CD123 Interactions [MoA], Cytotoxin [EPC], Cytotoxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72187-0401-1

1 VIAL, SINGLE-DOSE in 1 CARTON (72187-0401-1) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72187-0401-1 [72187040101]

Elzonris INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761116
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-18

Drug Details

Active Ingredients

Ingredient	Strength
TAGRAXOFUSP	1000 ug/mL

OpenFDA Data

• SPL SET ID: 80eb1080-fe20-4af0-b2a5-a67999923fa8
• Manufacturer:
  • Stemline Therapeutics, Inc.
• UNII:
  • 8ZHS5657EH
• RxNorm Concept Unique ID - RxCUI:
  • 2109064
  • 2109059
• UPC Code:
  • 0372187040118

Pharmacological Class

• CD123 Interaction [EPC]
• CD123 Interactions [MoA]
• Cytotoxin [EPC]
• Cytotoxins [CS]