FDA.reportPublic FDA data

FASENRA

Product NDC
0310-1830
11-digit product format
003101830
Labeler code
0310
Product ID
0310-1830_b78fbf2b-888c-41e2-bdab-cb5cd1ebb8fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benralizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
BLA761070
Marketing category
BLA
Marketing start
2019-10-04
Substance
BENRALIZUMAB
Active strength
30 mg/mL
Pharmacologic classes
Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA], Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FASENRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENRALIZUMAB30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
71492GE1FXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1989104Internal RxNorm lookup
1989109Internal RxNorm lookup
2205632Internal RxNorm lookup
2205634Internal RxNorm lookup
2679499Internal RxNorm lookup
2679502Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da6aca1a-19ed-44a4-abb7-696c7d58b784Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
acf12302-28d3-4d82-826e-7927090aa64dProduct name120180110
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-1830-30FASENRA1 in 1 CARTONINJECTION, SOLUTION127
0310-1830-30FASENRA1 mL in 1 CARTRIDGEINJECTION, SOLUTION127
0310-1830-85FASENRA1 in 1 CARTONINJECTION, SOLUTION127
0310-1830-85FASENRA1 mL in 1 CARTRIDGEINJECTION, SOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-1830-30ML - Milliliter0310-1830ec6eb83d-61c7-4015-8574-8138561bed9b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-1830FASENRA (BENRALIZUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]26Current NDC, Legacy NDC, 4 package rows20241018_da6aca1a-19ed-44a4-abb7-696c7d58b784.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FASENRABENRALIZUMABAstraZeneca Pharmaceuticals LPda6aca1a-19ed-44a4-abb7-696c7d58b7842026-05-13Warnings, Adverse reactionsExact identifier
application number: BLA761070
ndc (product): 0310-1830

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761070Fasenrabenralizumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679499benralizumab 10 MG in 0.5 ML Prefilled SyringePSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
2205632benralizumab 30 MG in 1 mL Auto-InjectorPSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
1989104benralizumab 30 MG in 1 ML Prefilled SyringePSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
2679502Fasenra 10 MG in 0.5 ML Prefilled SyringePSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
2205634Fasenra 30 MG in 1 mL Auto-InjectorPSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
1989109Fasenra 30 MG in 1 ML Prefilled SyringePSNda6aca1a-19ed-44a4-abb7-696c7d58b78427
26795020.5 ML benralizumab 20 MG/ML Prefilled Syringe [Fasenra]SBDda6aca1a-19ed-44a4-abb7-696c7d58b78427
22056341 ML benralizumab 30 MG/ML Auto-Injector [Fasenra]SBDda6aca1a-19ed-44a4-abb7-696c7d58b78427
19891091 ML benralizumab 30 MG/ML Prefilled Syringe [Fasenra]SBDda6aca1a-19ed-44a4-abb7-696c7d58b78427
26794990.5 ML benralizumab 20 MG/ML Prefilled SyringeSCDda6aca1a-19ed-44a4-abb7-696c7d58b78427
22056321 ML benralizumab 30 MG/ML Auto-InjectorSCDda6aca1a-19ed-44a4-abb7-696c7d58b78427
19891041 ML benralizumab 30 MG/ML Prefilled SyringeSCDda6aca1a-19ed-44a4-abb7-696c7d58b78427
26795020.5 ML Fasenra 20 MG/ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
22056341 ML Fasenra 30 MG/ML Auto-InjectorSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
19891091 ML Fasenra 30 MG/ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
2679499benralizumab 10 MG per 0.5 ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
2205632benralizumab 30 MG per 1 ML Auto-InjectorSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
1989104benralizumab 30 MG per 1 ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
2679502Fasenra 10 MG per 0.5 ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
2205634Fasenra 30 MG per 1 ML Auto-InjectorSYda6aca1a-19ed-44a4-abb7-696c7d58b78427
1989109Fasenra 30 MG per 1 ML Prefilled SyringeSYda6aca1a-19ed-44a4-abb7-696c7d58b78427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-1830-30003101830301 CARTRIDGE in 1 CARTON (0310-1830-30) / 1 mL in 1 CARTRIDGE1 cartridge2019-10-040000-00-00NoNoCurrent
0310-1830-85003101830851 CARTRIDGE in 1 CARTON (0310-1830-85) / 1 mL in 1 CARTRIDGE1 cartridge2019-10-040000-00-00YesNoCurrent