FDA.reportPublic FDA data

VYLOY

Product NDC
0469-4425
11-digit product format
004694425
Labeler code
0469
Product ID
0469-4425_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
2025-04-24
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 Identifiers#

Field, Values table
FieldValues
UniiTF5MPQ8WGY
Rxcui2695876, 2695882, 2710430, 2710432

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
0469-4425-30VYLOY1 in 1 BOXINJECTION, POWDER, FOR SUSPENSIO14
0469-4425-30VYLOY15 mL in 1 VIALINJECTION, POWDER, FOR SUSPENSIO154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-4425-30EA - Each0469-4425288fdd4f-4bbc-459f-9998-b1ae14c3906412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-4425VYLOY (ZOLBETUXIMAB) INJECTION, POWDER, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]3Current NDC, 2 package rows20250502_e7695a21-abb6-47ac-93f8-0ece5a9c4409.zip

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
0469-4425-30004694425301 VIAL in 1 BOX (0469-4425-30) / 15 mL in 1 VIAL1 vial2025-04-24NoNoHistorical