Eribulin Mesylate

Product NDC
81298-3890
11-digit product format
812983890
Labeler code
81298
Product ID
81298-3890_68589863-7488-4661-bbbe-9838b7d0396d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eribulin Mesylate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Long Grove Pharmaceuticals, LLC
Application
ANDA214850
Marketing category
ANDA
Marketing start
2024-07-22
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
81298-3890-1Eribulin Mesylate1 in 1 CARTONSOLUTION14
81298-3890-1Eribulin Mesylate2 mL in 1 VIAL, SINGLE-DOSESOLUTION24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-3890-1ML - Milliliter81298-3890e0e7e28a-7768-4277-a448-cd4995d400bc12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-3890ERIBULIN MESYLATE SOLUTION [LONG GROVE PHARMACEUTICALS, LLC]4Current NDC, 2 package rows20240801_4a64918a-f674-4843-b544-ab815fdd1b8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN4a64918a-f674-4843-b544-ab815fdd1b8f4
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD4a64918a-f674-4843-b544-ab815fdd1b8f4
1045456eribulin mesylate 1 MG per 2 ML InjectionSY4a64918a-f674-4843-b544-ab815fdd1b8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81298-3890-1812983890011 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSE2024-07-22NoNoCurrent