UPLIZNA
These highlights do not include all the information needed to use UPLIZNA safely and effectively. See full prescribing information for UPLIZNA . UPLIZNA ( i nebilizumab-cdon ) injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
834db232-afb0-4dcf-93e0-009ce8245c20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2021
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Inebilizumab
PRODUCT DETAILS
NDC Product Code75987-150
Application NumberBLA761142
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateJuly 27, 2021
Generic NameInebilizumab
INGREDIENTS (7)
INEBILIZUMABActive
Quantity: 10 mg in 1 mL
Code: 74T7185BMM
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 40.1 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
HISTIDINEInactive
Quantity: 1.4 mg in 1 mL
Code: 4QD397987E
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 2.3 mg in 1 mL
Code: X573657P6P
Classification: IACT