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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENFORTUMAB VEDOTIN30 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDLE8519RWM
Rxcui2268311, 2268315, 2268317, 2268319

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

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