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 Identifiers#

Field, Values table
FieldValues
Unii8ZHS5657EH
Rxcui2109059, 2109064

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

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