FDA.reportPublic FDA data

Lumvoa

Product NDC
85166-001
Requested package NDC
85166-001-01
11-digit product format
851660001
Labeler code
85166
Product ID
85166-001_b2e929f4-7a8c-4289-98aa-4f042e645c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
veligrotug
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Viridian Therapeutics, Inc.
Application
BLA761530
Marketing category
BLA
Marketing start
2026-06-26
Substance
VELIGROTUG
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lumvoa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VELIGROTUG50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z9U2SS9ZC8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2746009Internal RxNorm lookup
2746016Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11bc286a-5411-45af-af3f-69ad38efb610Available on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LumvoaVELIGROTUGViridian Therapeutics, Inc.11bc286a-5411-45af-af3f-69ad38efb6102026-06-29Warnings, Adverse reactionsExact identifier
application number: BLA761530
ndc (package): 85166-001-01
ndc (product): 85166-001
ndc11 (package): 85166000101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761530Lumvoaveligrotug-vvze351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85166-001-01851660001011 VIAL, SINGLE-DOSE in 1 CARTON (85166-001-01) / 10 mL in 1 VIAL, SINGLE-DOSE2026-06-26NoNoCurrent