ERIBULIN MESYLATE

Product NDC
40033-364
11-digit product format
400330364
Labeler code
40033
Product ID
40033-364_a57c0cca-c86f-4971-91f5-4f81893d47f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Kindos Pharmaceuticals Co., Ltd.
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
40033-364-01ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION24
40033-364-01ERIBULIN MESYLATE1 in 1 CARTONINJECTION14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN9bfd8ac7-57e2-4c9d-add8-26502cfb54a84
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD9bfd8ac7-57e2-4c9d-add8-26502cfb54a84
1045456eribulin mesylate 1 MG per 2 ML InjectionSY9bfd8ac7-57e2-4c9d-add8-26502cfb54a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
40033-364-01400330364011 VIAL, SINGLE-DOSE in 1 CARTON (40033-364-01) / 2 mL in 1 VIAL, SINGLE-DOSE2025-08-05NoNoCurrent