FDA.reportPublic FDA data

FASENRA

Product NDC
0310-1745
11-digit product format
003101745
Labeler code
0310
Product ID
0310-1745_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
2024-04-05
Substance
BENRALIZUMAB
Active strength
10 mg/.5mL
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
BENRALIZUMAB10 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71492GE1FX
Rxcui1989104, 1989109, 2205632, 2205634, 2679499, 2679502

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
0310-1745-01FASENRA1 in 1 CARTONINJECTION, SOLUTION127
0310-1745-01FASENRA0.5 mL in 1 CARTRIDGEINJECTION, SOLUTION0.527
0310-1745-95FASENRA1 in 1 CARTONINJECTION, SOLUTION127
0310-1745-95FASENRA0.5 mL in 1 CARTRIDGEINJECTION, SOLUTION0.527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-1745-01ML - Milliliter0310-17459f5043b7-19e0-4dd5-9172-2ce1c8e6cb3a12024-06-10
0310-1745-95ML - Milliliter0310-1745c0b8b619-aefb-454d-9714-127142870b0a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-1745FASENRA (BENRALIZUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]26Current NDC, 4 package rows20241018_da6aca1a-19ed-44a4-abb7-696c7d58b784.zip

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 startSampleExclude flagStatus
0310-1745-01003101745011 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE1 cartridge2024-06-03NoNoCurrent
0310-1745-95003101745951 CARTRIDGE in 1 CARTON (0310-1745-95) / .5 mL in 1 CARTRIDGE1 cartridge2024-06-03YesNoCurrent