daratumumab Injection

Brand(s)
Darzalex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Biotech, Inc. (2015-11-05)
Oldest Current Product
2015-11-16
License(s)
BLA
RxNORM
INJECTION\DARATUMUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DARATUMUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DARATUMUMAB

product(s) by strength(s)

5 ml daratumumab 20 mg/ml injection

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940502DarzalexBLAJanssen Biotech, Inc.2015-11-16DARATUMUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE761036a4d0efe9-5e54-467e-9eb4-56fa7d53b60b

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a4d0efe9-5e54-467e-9eb4-56fa7d53b60b (view SPL)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 useInitial U.S. Approval 2015prescriptionHuman PrescriptionJanssen Biotech, Inc.ANALYSIS, MANUFACTURE, PACK2015-11-052578940502

Data from: LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII