ADCETRIS

Product NDC
51144-050
11-digit product format
511440050
Labeler code
51144
Product ID
51144-050_a695c1a2-3acc-468b-a829-c8761dc041f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brentuximab vedotin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
SEAGEN INC.
Application
BLA125388
Marketing category
BLA
Marketing start
2011-08-25
Substance
BRENTUXIMAB VEDOTIN
Active strength
50 mg/10.5mL
Pharmacologic classes
CD30-directed Antibody Interactions [MoA], CD30-directed Immunoconjugate [EPC], Immunoconjugates [CS], Microtubule Inhibition [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRENTUXIMAB VEDOTIN50 mg/10.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7XL5ISS668Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147323Internal RxNorm lookup
1147327Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3904f8dd-1aef-3490-e48f-bd55f32ed67fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bf8fc9f-f560-42e5-9e32-fa6510e1f1e9Product name120190219
11401eca-a354-41d1-b11c-663bc46c8a40Product name120150818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51144-050-01ADCETRIS1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,138
51144-050-01ADCETRIS10.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,10.538

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51144-050-01EA - Each51144-0509d557333-cf25-48ef-b597-17d3596c578012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51144-050ADCETRIS (BRENTUXIMAB VEDOTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SEAGEN INC.]36Current NDC, Legacy NDC, 2 package rows20250221_3904f8dd-1aef-3490-e48f-bd55f32ed67f.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
ADCETRISBRENTUXIMAB VEDOTINSEAGEN INC.3904f8dd-1aef-3490-e48f-bd55f32ed67f2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125388
ndc (product): 51144-050

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125388Adcetrisbrentuximab vedotin351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147327Adcetris 50 MG InjectionPSN3904f8dd-1aef-3490-e48f-bd55f32ed67f38
1147323brentuximab vedotin 50 MG InjectionPSN3904f8dd-1aef-3490-e48f-bd55f32ed67f38
1147327brentuximab vedotin 50 MG Injection [Adcetris]SBD3904f8dd-1aef-3490-e48f-bd55f32ed67f38
1147323brentuximab vedotin 50 MG InjectionSCD3904f8dd-1aef-3490-e48f-bd55f32ed67f38
1147327Adcetris 50 MG InjectionSY3904f8dd-1aef-3490-e48f-bd55f32ed67f38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51144-050-01511440050011 VIAL, SINGLE-DOSE in 1 BOX (51144-050-01) / 10.5 mL in 1 VIAL, SINGLE-DOSE2011-08-250000-00-00NoNoCurrent