Eribulin Mesylate

Product NDC
0781-3391
11-digit product format
007813391
Labeler code
0781
Product ID
0781-3391_d122f0a4-aff7-49f7-8cf1-06bc2883ad43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA214310
Marketing category
ANDA
Marketing start
2025-07-07
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
Eribulin Mesylate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAV9U0660CW
Rxcui1045456

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
0781-3391-94Eribulin Mesylate2 mL in 1 VIALINJECTION21
0781-3391-94Eribulin Mesylate1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3391-94ML - Milliliter0781-3391a8f7cd17-71e2-4502-ab42-ef777fd3e2a112025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSNd122f0a4-aff7-49f7-8cf1-06bc2883ad431
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCDd122f0a4-aff7-49f7-8cf1-06bc2883ad431
1045456eribulin mesylate 1 MG per 2 ML InjectionSYd122f0a4-aff7-49f7-8cf1-06bc2883ad431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3391-94007813391941 VIAL in 1 CARTON (0781-3391-94) / 2 mL in 1 VIAL1 vial2025-07-07NoNoHistorical