FDA.reportPublic FDA data

Elzonris

Product NDC
72187-0401
11-digit product format
721870401
Labeler code
72187
Product ID
72187-0401_f219a6c1-2e94-40a7-8b66-28520f7bb7f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tagraxofusp
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Stemline Therapeutics, Inc.
Application
BLA761116
Marketing category
BLA
Marketing start
2019-01-18
Substance
TAGRAXOFUSP
Active strength
1000 ug/mL
Pharmacologic classes
CD123 Interaction [EPC], CD123 Interactions [MoA], Cytotoxin [EPC], Cytotoxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAGRAXOFUSP1000 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZHS5657EHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2109059Internal RxNorm lookup
2109064Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80eb1080-fe20-4af0-b2a5-a67999923fa8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
09f783da-ffc0-41a0-ae26-814dab35ee4cProduct name120190430

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72187-0401-1Elzonris1 in 1 CARTONINJECTION, SOLUTION111
72187-0401-1Elzonris1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72187-0401-1ML - Milliliter72187-040128ed12ca-5794-46d5-9e75-30fc03553b7e12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72187-0401ELZONRIS (TAGRAXOFUSP) INJECTION, SOLUTION [STEMLINE THERAPEUTICS, INC.]11Current NDC, Legacy NDC, 2 package rows20241212_80eb1080-fe20-4af0-b2a5-a67999923fa8.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
ElzonrisTAGRAXOFUSPStemline Therapeutics, Inc.80eb1080-fe20-4af0-b2a5-a67999923fa82024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761116
ndc (product): 72187-0401

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761116Elzonristagraxofusp-erzs351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109064ELZONRIS 1000 MCG in 1 ML InjectionPSN80eb1080-fe20-4af0-b2a5-a67999923fa811
2109059tagraxofusp-erzs 1 MG in 1 ML InjectionPSN80eb1080-fe20-4af0-b2a5-a67999923fa811
21090641 ML tagraxofusp-erzs 1 MG/ML Injection [Elzonris]SBD80eb1080-fe20-4af0-b2a5-a67999923fa811
21090591 ML tagraxofusp-erzs 1 MG/ML InjectionSCD80eb1080-fe20-4af0-b2a5-a67999923fa811
21090641 ML Elzonris 1 MG/ML InjectionSY80eb1080-fe20-4af0-b2a5-a67999923fa811
2109059tagraxofusp-erzs 1 MG per 1 ML InjectionSY80eb1080-fe20-4af0-b2a5-a67999923fa811
2109059tagraxofusp-erzs 1000 MCG per 1 ML InjectionSY80eb1080-fe20-4af0-b2a5-a67999923fa811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72187-0401-1721870401011 VIAL, SINGLE-DOSE in 1 CARTON (72187-0401-1) / 1 mL in 1 VIAL, SINGLE-DOSE2019-01-180000-00-00NoNoCurrent