Eribulin Mesylate

Product NDC
68001-656
11-digit product format
680010656
Labeler code
68001
Product ID
68001-656_4ddb9eb5-66c7-ffdd-e063-6294a90adfb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eribulin Mesylate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA214850
Marketing category
ANDA
Marketing start
2025-10-08
Substance
ERIBULIN MESYLATE
Active strength
.5 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eribulin Mesylate
Listing expiration
2027-12-31

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
68001-656-41Eribulin Mesylate2 mL in 1 VIAL, SINGLE-DOSESOLUTION22
68001-656-41Eribulin Mesylate1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-656-41ML - Milliliter68001-656e9512fc9-f034-44fe-908b-fcdea4ac26d712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN1a1a9cff-d5da-4232-b98f-26f55208dfc42
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD1a1a9cff-d5da-4232-b98f-26f55208dfc42
1045456eribulin mesylate 1 MG per 2 ML InjectionSY1a1a9cff-d5da-4232-b98f-26f55208dfc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-656-41680010656411 VIAL, SINGLE-DOSE in 1 CARTON (68001-656-41) / 2 mL in 1 VIAL, SINGLE-DOSE2025-10-08NoNoCurrent