NDC 0310-1730

FASENRA

Benralizumab

FASENRA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Benralizumab.

• Product ID: 0310-1730_220fd267-9bb7-49d6-a86f-a0fd6718ac46
• NDC: 0310-1730
• Product Type: Human Prescription Drug
• Proprietary Name: FASENRA
• Generic Name: Benralizumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-11-14
• Marketing Category: BLA / BLA
• Application Number: BLA761070
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: BENRALIZUMAB
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC],Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-1730-30

1 SYRINGE, GLASS in 1 CARTON (0310-1730-30) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2017-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-1730-85 [00310173085]

FASENRA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761070
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-14

NDC 0310-1730-30 [00310173030]

FASENRA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761070
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-14

Drug Details

Active Ingredients

Ingredient	Strength
BENRALIZUMAB	30 mg/mL

OpenFDA Data

• SPL SET ID: da6aca1a-19ed-44a4-abb7-696c7d58b784
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 71492GE1FX
• RxNorm Concept Unique ID - RxCUI:
  • 1989104
  • 1989109

Pharmacological Class

• Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]
• Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA]

NDC Crossover Matching brand name "FASENRA" or generic name "Benralizumab"

NDC	Brand Name	Generic Name
0310-1730	FASENRA	Benralizumab
0310-1830	FASENRA	Benralizumab