eribulin mesylate

Product NDC
60505-6435
11-digit product format
605056435
Labeler code
60505
Product ID
60505-6435_69c87b29-2670-aa40-b36a-40df421adb14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA218047
Marketing category
ANDA
Marketing start
2025-03-19
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
60505-6435-0eribulin mesylate2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
60505-6435-0eribulin mesylate1 in 1 CARTONINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6435ERIBULIN MESYLATE INJECTION [APOTEX CORP.]1Current NDC, 2 package rows20250322_64bf3c30-f06a-3615-ca5e-eb4154d371d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN64bf3c30-f06a-3615-ca5e-eb4154d371d01
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD64bf3c30-f06a-3615-ca5e-eb4154d371d01
1045456eribulin mesylate 1 MG per 2 ML InjectionSY64bf3c30-f06a-3615-ca5e-eb4154d371d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6435-0605056435001 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0) / 2 mL in 1 VIAL, SINGLE-DOSE2025-03-19NoNoHistorical