FDA.reportPublic FDA data

PADCEV

Product NDC
51144-030
11-digit product format
511440030
Labeler code
51144
Product ID
51144-030_33307968-30bb-4890-8163-a24aec6b4520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENFORTUMAB VEDOTIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
SEAGEN INC.
Application
BLA761137
Marketing category
BLA
Marketing start
2019-12-18
Substance
ENFORTUMAB VEDOTIN
Active strength
30 mg/3mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PADCEV
Brand name suffix
EJFV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENFORTUMAB VEDOTIN30 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DLE8519RWMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2268311Internal RxNorm lookup
2268315Internal RxNorm lookup
2268317Internal RxNorm lookup
2268319Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5631d3e-4604-4363-8f20-11dfc5a4a8edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77ce9fbe-f1ea-4ab6-9c06-0d6391e0e026Product name120200604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51144-030-01PADCEVEJFV3 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,316
51144-030-01PADCEVEJFV1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51144-030-01EA - Each51144-03022c5a52e-740d-4b46-b9ce-6b55936fa8d912020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51144-030PADCEV EJFV (ENFORTUMAB VEDOTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SEAGEN INC.]15Current NDC, Legacy NDC, 2 package rows20250316_b5631d3e-4604-4363-8f20-11dfc5a4a8ed.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
PADCEV EJFVENFORTUMAB VEDOTINSEAGEN INC.b5631d3e-4604-4363-8f20-11dfc5a4a8ed2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761137
ndc (product): 51144-030

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761137Padcevenfortumab vedotin-ejfv351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2268311enfortumab vedotin-ejfv 20 MG InjectionPSNb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268317enfortumab vedotin-ejfv 30 MG InjectionPSNb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268315PADCEV 20 MG InjectionPSNb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268319PADCEV 30 MG InjectionPSNb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268315enfortumab vedotin-ejfv 20 MG Injection [Padcev]SBDb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268319enfortumab vedotin-ejfv 30 MG Injection [Padcev]SBDb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268311enfortumab vedotin-ejfv 20 MG InjectionSCDb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268317enfortumab vedotin-ejfv 30 MG InjectionSCDb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268315Padcev 20 MG InjectionSYb5631d3e-4604-4363-8f20-11dfc5a4a8ed16
2268319Padcev 30 MG InjectionSYb5631d3e-4604-4363-8f20-11dfc5a4a8ed16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51144-030-01511440030011 VIAL, SINGLE-DOSE in 1 BOX (51144-030-01) / 3 mL in 1 VIAL, SINGLE-DOSE2019-12-180000-00-00NoNoCurrent