BEOVU

Product NDC: 0078-0827
Requested package NDC: 0078-0827-99
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0827	0078-0827-99	D	Discontinued by firm		2026-08-07

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb9fb3d0-13ff-4090-b463-8897d95f90fa	Product name	1	20200305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0827-60	ML - Milliliter	0078-0827	283dea16-4acc-43d2-a9fb-e698155c290f	1	2022-06-06
0078-0827-61	ML - Milliliter	0078-0827	51c21738-2e6c-46d0-b1e5-55dc7133334b	1	2019-11-12

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 (package): 0078-0827-99 ndc (product): 0078-0827 ndc11 (package): 00078082799

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XSZ53G39H5	BROLUCIZUMAB	1531589-13-5	BROLUCIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2204925	Beovu 6 MG in 0.05 ML Injection	PSN	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602279	Beovu 6 MG in 0.05 ML Prefilled Syringe	PSN	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204920	brolucizumab-dbll 6 MG in 0.05 ML Injection	PSN	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602276	brolucizumab-dbll 6 MG in 0.05 ML Prefilled Syringe	PSN	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204925	0.05 ML brolucizumab-dbll 120 MG/ML Injection [Beovu]	SBD	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602279	0.05 ML brolucizumab-dbll 120 MG/ML Prefilled Syringe [Beovu]	SBD	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204920	0.05 ML brolucizumab-dbll 120 MG/ML Injection	SCD	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602276	0.05 ML brolucizumab-dbll 120 MG/ML Prefilled Syringe	SCD	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204925	Beovu 120 MG/ML per 0.05 ML Injection	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602279	Beovu 120 MG/ML per 0.05 ML Prefilled Syringe	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204925	Beovu 6 MG per 0.05 ML Injection	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602279	Beovu 6 MG per 0.05 ML Prefilled Syringe	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204920	brolucizumab-dbll 120 MG/ML per 0.05 ML Injection	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602276	brolucizumab-dbll 120 MG/ML per 0.05 ML Prefilled Syringe	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2204920	brolucizumab-dbll 6 MG per 0.05 ML Injection	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16
2602276	brolucizumab-dbll 6 MG per 0.05 ML Prefilled Syringe	SY	5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0827-99	00078082799	1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-99) > .05 mL in 1 VIAL, SINGLE-DOSE	2019-10-07	2023-02-28	Yes	No	Current