ERIBULIN MESYLATE

Product NDC
68462-770
11-digit product format
684620770
Labeler code
68462
Product ID
68462-770_ea76510b-f764-478c-b6c4-cdc955a6276b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA218142
Marketing category
ANDA
Marketing start
2025-08-05
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
68462-770-20ERIBULIN MESYLATE1 in 1 CARTONINJECTION12
68462-770-20ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-770-20ML - Milliliter68462-770ff5504cb-9bf4-438a-9987-0507d72264e412025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN55f4017d-5ea8-4622-bf59-9b9c329097fd2
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD55f4017d-5ea8-4622-bf59-9b9c329097fd2
1045456eribulin mesylate 1 MG per 2 ML InjectionSY55f4017d-5ea8-4622-bf59-9b9c329097fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-770-20684620770201 VIAL, SINGLE-DOSE in 1 CARTON (68462-770-20) / 2 mL in 1 VIAL, SINGLE-DOSE2025-08-05NoNoCurrent