DARZALEX
These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015
Approved
Approval ID
a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
Janssen Biotech, Inc.
DUNS: 099091753
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daratumumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-502
Application NumberBLA761036
Product Classification
M
Marketing Category
C73585
G
Generic Name
Daratumumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (7)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DARATUMUMABActive
Quantity: 100 mg in 5 mL
Code: 4Z63YK6E0E
Classification: ACTIB
Daratumumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-505
Application NumberBLA761036
Product Classification
M
Marketing Category
C73585
G
Generic Name
Daratumumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (7)
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
DARATUMUMABActive
Quantity: 100 mg in 5 mL
Code: 4Z63YK6E0E
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT