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
0ce5e7f6-eb97-4738-8b10-43b89e16b5b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2020
Manufacturers
FDA
Viela Bio, Inc.
DUNS: 081141620
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Inebilizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72677-551
Application NumberBLA761142
Product Classification
M
Marketing Category
C73585
G
Generic Name
Inebilizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2020
FDA Product Classification
INGREDIENTS (7)
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 2.3 mg in 1 mL
Code: X573657P6P
Classification: IACT
INEBILIZUMABActive
Quantity: 10 mg in 1 mL
Code: 74T7185BMM
Classification: ACTIB
HISTIDINEInactive
Quantity: 1.4 mg in 1 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 40.1 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT