FDA.reportPublic FDA data

VYLOY

Product NDC
0469-3425
11-digit product format
004693425
Labeler code
0469
Product ID
0469-3425_eec900c3-1365-4353-836e-c5e483e43f6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLBETUXIMAB
Dosage form
INJECTION, POWDER, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Astellas Pharma US, Inc.
Application
BLA761365
Marketing category
BLA
Marketing start
2024-10-24
Substance
ZOLBETUXIMAB
Active strength
20 mg/mL
Pharmacologic classes
Claudin 18.2-directed Antibody Interactions [MoA], Claudin 18.2-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VYLOY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLBETUXIMAB20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TF5MPQ8WGYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2695876Internal RxNorm lookup
2695882Internal RxNorm lookup
2710430Internal RxNorm lookup
2710432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7695a21-abb6-47ac-93f8-0ece5a9c4409Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c0b30ef-7103-4132-abaf-dc1b1cf04c89Product name120250515
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-3425-10VYLOY5 mL in 1 VIALINJECTION, POWDER, FOR SUSPENSIO54
0469-3425-10VYLOY1 in 1 BOXINJECTION, POWDER, FOR SUSPENSIO14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-3425-10EA - Each0469-342579c38152-4421-4464-81c9-a616320e144c12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-3425VYLOY (ZOLBETUXIMAB) INJECTION, POWDER, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]3Current NDC, 2 package rows20250502_e7695a21-abb6-47ac-93f8-0ece5a9c4409.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYLOYZOLBETUXIMABAstellas Pharma US, Inc.e7695a21-abb6-47ac-93f8-0ece5a9c44092025-06-12Warnings, Adverse reactionsExact identifier
application number: BLA761365
ndc (product): 0469-3425

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761365Vyloyzolbetuximab-clzb351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695882VYLOY 100 MG InjectionPSNe7695a21-abb6-47ac-93f8-0ece5a9c44094
2710432VYLOY 300 MG InjectionPSNe7695a21-abb6-47ac-93f8-0ece5a9c44094
2695876zolbetuximab-clzb 100 MG InjectionPSNe7695a21-abb6-47ac-93f8-0ece5a9c44094
2710430zolbetuximab-clzb 300 MG InjectionPSNe7695a21-abb6-47ac-93f8-0ece5a9c44094
2695882zolbetuximab-clzb 100 MG Injection [Vyloy]SBDe7695a21-abb6-47ac-93f8-0ece5a9c44094
2710432zolbetuximab-clzb 300 MG Injection [Vyloy]SBDe7695a21-abb6-47ac-93f8-0ece5a9c44094
2695876zolbetuximab-clzb 100 MG InjectionSCDe7695a21-abb6-47ac-93f8-0ece5a9c44094
2710430zolbetuximab-clzb 300 MG InjectionSCDe7695a21-abb6-47ac-93f8-0ece5a9c44094
2695882Vyloy 100 MG InjectionSYe7695a21-abb6-47ac-93f8-0ece5a9c44094
2710432Vyloy 300 MG InjectionSYe7695a21-abb6-47ac-93f8-0ece5a9c44094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0469-3425-10004693425101 VIAL in 1 BOX (0469-3425-10) / 5 mL in 1 VIAL1 vial2024-10-24NoNoCurrent