ERIBULIN MESYLATE

Product NDC
39822-2080
11-digit product format
398222080
Labeler code
39822
Product ID
39822-2080_4d3aa580-669b-dddb-e063-6294a90a1152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA219054
Marketing category
ANDA
Marketing start
2026-04-07
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
39822-2080-1ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
39822-2080-1ERIBULIN MESYLATE1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-2080-1ML - Milliliter39822-20807e5e4cd1-c130-453a-b510-6d3954879e9712026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN4d3a9ac3-10e9-cad5-e063-6394a90a461f1
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD4d3a9ac3-10e9-cad5-e063-6394a90a461f1
1045456eribulin mesylate 1 MG per 2 ML InjectionSY4d3a9ac3-10e9-cad5-e063-6394a90a461f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
39822-2080-1398222080011 VIAL, SINGLE-DOSE in 1 CARTON (39822-2080-1) / 2 mL in 1 VIAL, SINGLE-DOSE2026-04-07NoNoCurrent