Eribulin Mesylate

Product NDC
72603-368
11-digit product format
726030368
Labeler code
72603
Product ID
72603-368_3ec12ffb-c2ea-464d-9f47-3c8a733eb88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eribulin Mesylate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA214850
Marketing category
ANDA
Marketing start
2025-12-05
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
72603-368-01Eribulin Mesylate1 in 1 CARTONSOLUTION11
72603-368-01Eribulin Mesylate2 mL in 1 VIAL, SINGLE-DOSESOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-368-01ML - Milliliter72603-3684aba10f2-4d85-4c46-b855-9cc7a3c9afae12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN5caedc93-c3c4-45e5-a2c6-0ce0698605841
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD5caedc93-c3c4-45e5-a2c6-0ce0698605841
1045456eribulin mesylate 1 MG per 2 ML InjectionSY5caedc93-c3c4-45e5-a2c6-0ce0698605841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-368-01726030368011 VIAL, SINGLE-DOSE in 1 CARTON (72603-368-01) / 2 mL in 1 VIAL, SINGLE-DOSE2025-12-05NoNoHistorical