NDC 57894-503

Darzalex Faspro

Daratumumab And Hyaluronidase-fihj (human Recombinant)

Darzalex Faspro is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Daratumumab; Hyaluronidase (human Recombinant).

• Product ID: 57894-503_31006ad8-638c-11ea-8b95-4d54fc2ca371
• NDC: 57894-503
• Product Type: Human Prescription Drug
• Proprietary Name: Darzalex Faspro
• Generic Name: Daratumumab And Hyaluronidase-fihj (human Recombinant)
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2020-05-01
• Marketing Category: BLA / BLA
• Application Number: BLA761145
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
• Active Ingredient Strength: 1800 mg/15mL; U/15mL
• Pharm Classes: CD38-directed Cytolytic Antibody [EPC],CD38-directed Antibody Interactions [MoA],Antibodies, Monoclonal [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 57894-503-01

1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) > 15 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2020-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-503-01 [57894050301]

Darzalex Faspro INJECTION

• Marketing Category: BLA
• Application Number: BLA761145
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-01

Drug Details

Active Ingredients

Ingredient	Strength
DARATUMUMAB	1800 mg/15mL

Pharmacological Class

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