Halaven

Product NDC
62856-389
11-digit product format
628560389
Labeler code
62856
Product ID
62856-389_2c75a415-0b1e-4c36-8301-c50ac155d980
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eisai Inc.
Application
NDA201532
Marketing category
NDA
Marketing start
2010-11-15
Substance
ERIBULIN MESYLATE
Active strength
.5 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERIBULIN MESYLATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAV9U0660CW
Rxcui1045456, 1045460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2cc096b-1048-9b7c-d909-76a5ea566cbfProduct name320251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62856-389-01Halaven1 in 1 CARTONINJECTION169
62856-389-01Halaven2 mL in 1 VIAL, SINGLE-DOSEINJECTION269

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62856-389-01ML - Milliliter62856-389276a5e85-cbac-4c5a-b1ec-58463037f8bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERIBULIN MESYLATEACTIVE INGREDIENTAV9U0660CWHALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.]39
ERIBULINACTIVE MOIETYLR24G6354GHALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.]39
ALCOHOLINACTIVE INGREDIENT3K9958V90MHALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.]39
WATERINACTIVE INGREDIENT059QF0KO0RHALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.]39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-389HALAVEN (ERIBULIN MESYLATE) INJECTION [EISAI INC.]68Current NDC, Legacy NDC, 2 package rows20241120_31ce4750-ded5-4a0b-95e9-f229fa6bc822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN31ce4750-ded5-4a0b-95e9-f229fa6bc82269
1045460Halaven 1 MG in 2 ML InjectionPSN31ce4750-ded5-4a0b-95e9-f229fa6bc82269
10454602 ML eribulin mesylate 0.5 MG/ML Injection [Halaven]SBD31ce4750-ded5-4a0b-95e9-f229fa6bc82269
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD31ce4750-ded5-4a0b-95e9-f229fa6bc82269
10454602 ML Halaven 0.5 MG/ML InjectionSY31ce4750-ded5-4a0b-95e9-f229fa6bc82269
1045456eribulin mesylate 1 MG per 2 ML InjectionSY31ce4750-ded5-4a0b-95e9-f229fa6bc82269
1045460Halaven 1 MG per 2 ML InjectionSY31ce4750-ded5-4a0b-95e9-f229fa6bc82269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62856-389-01628560389011 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) / 2 mL in 1 VIAL, SINGLE-DOSE2010-11-150000-00-00NoNoCurrent