FASENRA
These highlights do not include all the information needed to use FASENRA safely and effectively. See full prescribing information for FASENRA.FASENRA (benralizumab) injection, for subcutaneous useInitial U.S. Approval: 2017
Approved
Approval ID
da6aca1a-19ed-44a4-abb7-696c7d58b784
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2021
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benralizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-1730
Application NumberBLA761070
Product Classification
M
Marketing Category
C73585
G
Generic Name
Benralizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 23, 2021
FDA Product Classification
INGREDIENTS (6)
HISTIDINE MONOHYDROCHLORIDEInactive
Quantity: 2.3 mg in 1 mL
Code: 1D5Q932XM6
Classification: IACT
BENRALIZUMABActive
Quantity: 30 mg in 1 mL
Code: 71492GE1FX
Classification: ACTIB
WATERInactive
Quantity: 910 mg in 1 mL
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.06 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
HISTIDINEInactive
Quantity: 1.4 mg in 1 mL
Code: 4QD397987E
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 95 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
Benralizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-1830
Application NumberBLA761070
Product Classification
M
Marketing Category
C73585
G
Generic Name
Benralizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 23, 2021
FDA Product Classification
INGREDIENTS (6)
BENRALIZUMABActive
Quantity: 30 mg in 1 mL
Code: 71492GE1FX
Classification: ACTIB
HISTIDINEInactive
Quantity: 1.4 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Quantity: 2.3 mg in 1 mL
Code: 1D5Q932XM6
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.06 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 95 mg in 1 mL
Code: 7YIN7J07X4
Classification: IACT
WATERInactive
Quantity: 910 mg in 1 mL
Code: 059QF0KO0R
Classification: IACT