NDC 0310-4500

IMFINZI

Durvalumab

IMFINZI is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Durvalumab.

• Product ID: 0310-4500_033cbc7e-d910-4629-ad38-abcdc3c6ddbb
• NDC: 0310-4500
• Product Type: Human Prescription Drug
• Proprietary Name: IMFINZI
• Generic Name: Durvalumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-05-01
• Marketing Category: BLA / BLA
• Application Number: BLA761069
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: DURVALUMAB
• Active Ingredient Strength: 120 mg/2.4mL
• Pharm Classes: Programmed Death Ligand-1 Antagonists [MoA],Programmed Death Ligand-1-directed Antibody Interactions [MoA],Antibodies, Monoclonal [CS],Programmed Death Ligand-1 Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-4500-12

1 VIAL in 1 CARTON (0310-4500-12) > 2.4 mL in 1 VIAL

• Marketing Start Date: 2017-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-4500-12 [00310450012]

IMFINZI INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761069
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-01

Drug Details

Active Ingredients

Ingredient	Strength
DURVALUMAB	120 mg/2.4mL

OpenFDA Data

• SPL SET ID: 8baba4ea-2855-42fa-9bd9-5a7548d4cec3
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 28X28X9OKV
• RxNorm Concept Unique ID - RxCUI:
  • 1919507
  • 1919512
  • 1919515
  • 1919516

Pharmacological Class

• Programmed Death Ligand-1 Antagonists [MoA]
• Programmed Death Ligand-1-directed Antibody Interactions [MoA]
• Antibodies
• Monoclonal [CS]
• Programmed Death Ligand-1 Blocker [EPC]

NDC Crossover Matching brand name "IMFINZI" or generic name "Durvalumab"

NDC	Brand Name	Generic Name
0310-4500	IMFINZI	Durvalumab
0310-4611	IMFINZI	Durvalumab