fasenra

Generic: benralizumab

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name fasenra
Generic Name benralizumab
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

benralizumab 10 mg/.5mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-1745
Product ID 0310-1745_901977cc-c730-4b8b-9faf-ca24afc3589a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761070
Listing Expiration 2026-12-31
Marketing Start 2024-04-05

Pharmacologic Class

Established (EPC)
interleukin-5 receptor alpha-directed cytolytic antibody [epc]
Mechanism of Action
interleukin 5 receptor alpha-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03101745
Hyphenated Format 0310-1745

Supplemental Identifiers

RxCUI
1989104 1989109 2205632 2205634 2679499 2679502
UNII
71492GE1FX
NUI
N0000193803 N0000193802

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fasenra (source: ndc)
Generic Name benralizumab (source: ndc)
Application Number BLA761070 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/.5mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE
  • 1 CARTRIDGE in 1 CARTON (0310-1745-95) / .5 mL in 1 CARTRIDGE
source: ndc

Packages (2)

0310-1745-01 1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE 0310-1745-95 1 CARTRIDGE in 1 CARTON (0310-1745-95) / .5 mL in 1 CARTRIDGE

Ingredients (1)

benralizumab (10 mg/.5mL)

Linked Drug Pages (1)

FASENRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "901977cc-c730-4b8b-9faf-ca24afc3589a", "openfda": {"nui": ["N0000193803", "N0000193802"], "unii": ["71492GE1FX"], "rxcui": ["1989104", "1989109", "2205632", "2205634", "2679499", "2679502"], "spl_set_id": ["da6aca1a-19ed-44a4-abb7-696c7d58b784"], "pharm_class_epc": ["Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0310-1745-01)  / .5 mL in 1 CARTRIDGE", "package_ndc": "0310-1745-01", "marketing_start_date": "20240603"}, {"sample": true, "description": "1 CARTRIDGE in 1 CARTON (0310-1745-95)  / .5 mL in 1 CARTRIDGE", "package_ndc": "0310-1745-95", "marketing_start_date": "20240603"}], "brand_name": "FASENRA", "product_id": "0310-1745_901977cc-c730-4b8b-9faf-ca24afc3589a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA]", "Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]"], "product_ndc": "0310-1745", "generic_name": "Benralizumab", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FASENRA", "active_ingredients": [{"name": "BENRALIZUMAB", "strength": "10 mg/.5mL"}], "application_number": "BLA761070", "marketing_category": "BLA", "marketing_start_date": "20240405", "listing_expiration_date": "20261231"}