Home NDC 0078-0827 BEOVU
Product NDC 0078-0827
11-digit product format 000780827
Labeler code 0078
Product ID 0078-0827_8b8e71f4-7d7e-40b5-a942-89ac3b6c0c6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brolucizumab
Dosage form INJECTION, SOLUTION
Route INTRAVITREAL
Labeler Novartis Pharmaceuticals Corporation
Application BLA761125
Marketing category BLA
Marketing start 2019-10-07
Substance BROLUCIZUMAB
Active strength 6 mg/.05mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Additional Listing Data#
Finished product Yes
Brand name base BEOVU
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROLUCIZUMAB 6 mg/.05mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XSZ53G39H5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2204920 Internal RxNorm lookup 2204925 Internal RxNorm lookup 2602276 Internal RxNorm lookup 2602279 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0827-60 BEOVU 0.05 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.05 16 0078-0827-60 BEOVU 1 in 1 CARTON INJECTION, SOLUTION 1 16 0078-0827-61 BEOVU 1 in 1 CARTON INJECTION, SOLUTION 1 16 0078-0827-61 BEOVU 0.05 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 0.05 16 0078-0827-98 BEOVU 1 in 1 CARTON INJECTION, SOLUTION 1 16 0078-0827-98 BEOVU 0.05 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.05 16 0078-0827-99 BEOVU 1 in 1 CARTON INJECTION, SOLUTION 1 16 0078-0827-99 BEOVU 0.05 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 0.05 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0827 BEOVU (BROLUCIZUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 15 Current NDC, Legacy NDC, 8 package rows 20250226_5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BEOVU BROLUCIZUMAB Novartis Pharmaceuticals Corporation 5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d 2025-11-03 Warnings, Adverse reactions Exact identifier application number: BLA761125 ndc (product): 0078-0827
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761125 Beovu brolucizumab-dbll 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0827-60 00078082760 1 SYRINGE, GLASS in 1 CARTON (0078-0827-60) / .05 mL in 1 SYRINGE, GLASS 2022-03-09 0000-00-00 No No Current 0078-0827-61 00078082761 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-61) > .05 mL in 1 VIAL, SINGLE-DOSE 2019-10-07 0000-00-00 No No Current 0078-0827-98 00078082798 1 SYRINGE, GLASS in 1 CARTON (0078-0827-98) / .05 mL in 1 SYRINGE, GLASS 2022-03-09 0000-00-00 Yes No Current 0078-0827-99 00078082799 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-99) > .05 mL in 1 VIAL, SINGLE-DOSE 2019-10-07 0000-00-00 Yes No Current