eribulin mesylate

Product NDC
60505-6289
11-digit product format
605056289
Labeler code
60505
Product ID
60505-6289_f468a7c7-87bd-afa0-2a13-b0ec564dd3ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA218047
Marketing category
ANDA
Marketing start
2024-05-06
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
60505-6289-0eribulin mesylate1 in 1 CARTONINJECTION12
60505-6289-0eribulin mesylate2 mL in 1 VIAL, SINGLE-DOSEINJECTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6289-0ML - Milliliter60505-6289d5e2f4bd-2543-4268-83c4-f483395af1cd12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6289ERIBULIN MESYLATE INJECTION [APOTEX CORP.]1Current NDC, 2 package rows20240509_7752b084-cdc7-6eac-e294-e45db82c372a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN7752b084-cdc7-6eac-e294-e45db82c372a2
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD7752b084-cdc7-6eac-e294-e45db82c372a2
1045456eribulin mesylate 1 MG per 2 ML InjectionSY7752b084-cdc7-6eac-e294-e45db82c372a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6289-0605056289001 VIAL, SINGLE-DOSE in 1 CARTON (60505-6289-0) / 2 mL in 1 VIAL, SINGLE-DOSE2024-05-06NoNoHistorical