NDC 57894-502

DARZALEX

Daratumumab

DARZALEX is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Daratumumab.

• Product ID: 57894-502_01d20c9e-ad31-481b-a70d-4a488353beba
• NDC: 57894-502
• Product Type: Human Prescription Drug
• Proprietary Name: DARZALEX
• Generic Name: Daratumumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-11-16
• Marketing Category: BLA / BLA
• Application Number: BLA761036
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: DARATUMUMAB
• Active Ingredient Strength: 100 mg/5mL
• Pharm Classes: CD38-directed Cytolytic Antibody [EPC],CD38-directed Antibody Interactions [MoA],Antibodies, Monoclonal [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 57894-502-05

1 VIAL in 1 CARTON (57894-502-05) > 5 mL in 1 VIAL

• Marketing Start Date: 2015-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-502-20 [57894050220]

DARZALEX INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA761036
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-16

NDC 57894-502-05 [57894050205]

DARZALEX INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA761036
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-16

Drug Details

Active Ingredients

Ingredient	Strength
DARATUMUMAB	100 mg/5mL

OpenFDA Data

• SPL SET ID: a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • 4Z63YK6E0E
• RxNorm Concept Unique ID - RxCUI:
  • 1721951
  • 1721956
• UPC Code:
  • 0357894502050

Pharmacological Class

• CD38-directed Cytolytic Antibody [EPC]
• CD38-directed Antibody Interactions [MoA]
• Antibodies
• Monoclonal [CS]

NDC Crossover Matching brand name "DARZALEX" or generic name "Daratumumab"

NDC	Brand Name	Generic Name
57894-502	DARZALEX	Daratumumab
57894-505	Darzalex IV	Daratumumab