Eribulin Mesylate

Product NDC
10019-080
11-digit product format
100190080
Labeler code
10019
Product ID
10019-080_d075592c-a613-41ff-975a-e0855110fb75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eribulin Mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA217250
Marketing category
ANDA
Marketing start
2024-10-01
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
10019-080-01Eribulin Mesylate1 in 1 CARTONINJECTION14
10019-080-01Eribulin Mesylate2 mL in 1 VIAL, SINGLE-DOSEINJECTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-080ERIBULIN MESYLATE INJECTION [BAXTER HEALTHCARE COMPANY]2Current NDC, 2 package rows20250514_62690292-b1de-46f1-b6e8-012a725f8c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN62690292-b1de-46f1-b6e8-012a725f8c634
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD62690292-b1de-46f1-b6e8-012a725f8c634
1045456eribulin mesylate 1 MG per 2 ML InjectionSY62690292-b1de-46f1-b6e8-012a725f8c634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10019-080-01100190080011 VIAL, SINGLE-DOSE in 1 CARTON (10019-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE2024-12-01NoNoCurrent