Eribulin Mesylate

Product NDC
43598-125
11-digit product format
435980125
Labeler code
43598
Product ID
43598-125_5b72f089-3089-d1f4-1138-d21ea2958492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eribulin Mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA217473
Marketing category
ANDA
Marketing start
2026-01-22
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-125-11Eribulin Mesylate2 mL in 1 VIAL, SINGLE-DOSEINJECTION25
43598-125-11Eribulin Mesylate1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-125-11ML - Milliliter43598-12533d41149-e08a-4c9b-a773-a71da8858cd512026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN1038e984-3bf7-5bbf-f1ec-ce15ae330efc5
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD1038e984-3bf7-5bbf-f1ec-ce15ae330efc5
1045456eribulin mesylate 1 MG per 2 ML InjectionSY1038e984-3bf7-5bbf-f1ec-ce15ae330efc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-125-11435980125111 VIAL, SINGLE-DOSE in 1 CARTON (43598-125-11) / 2 mL in 1 VIAL, SINGLE-DOSE2026-01-22NoNoCurrent