NDC 0078-0827

BEOVU

Brolucizumab

BEOVU is a Intravitreal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Brolucizumab.

• Product ID: 0078-0827_2195eb7c-9895-45dc-8e49-ee0451b8e036
• NDC: 0078-0827
• Product Type: Human Prescription Drug
• Proprietary Name: BEOVU
• Generic Name: Brolucizumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVITREAL
• Marketing Start Date: 2019-10-07
• Marketing Category: BLA / BLA
• Application Number: BLA761125
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: BROLUCIZUMAB
• Active Ingredient Strength: 6 mg/.05mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0827-61

1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-61) > .05 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-10-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0827-61 [00078082761]

BEOVU INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761125
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-10-07

NDC 0078-0827-99 [00078082799]

BEOVU INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761125
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-07

Drug Details

Active Ingredients

Ingredient	Strength
BROLUCIZUMAB	6 mg/.05mL

OpenFDA Data

• SPL SET ID: 5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • XSZ53G39H5
• RxNorm Concept Unique ID - RxCUI:
  • 2204925
  • 2204920