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Darzalex Faspro

These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020

Approved
Approval ID

4bb241af-4299-4373-8762-2d6709515db0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2023

Manufacturers
FDA

Janssen Biotech, Inc.

DUNS: 099091753

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

daratumumab and hyaluronidase-fihj (human recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57894-503
Application NumberBLA761145
Product Classification
M
Marketing Category
C73585
G
Generic Name
daratumumab and hyaluronidase-fihj (human recombinant)
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 28, 2023
FDA Product Classification

INGREDIENTS (8)

HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DARATUMUMABActive
Quantity: 1800 mg in 15 mL
Code: 4Z63YK6E0E
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 30000 U in 15 mL
Code: 743QUY4VD8
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT

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