ERIBULIN MESYLATE

Product NDC
70095-080
11-digit product format
700950080
Labeler code
70095
Product ID
70095-080_2c0e145b-96b0-4f7b-8993-0f5f59afa81d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERIBULIN MESYLATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries Limited
Application
ANDA218743
Marketing category
ANDA
Marketing start
2025-05-15
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
70095-080-01ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
70095-080-01ERIBULIN MESYLATE1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70095-080-01ML - Milliliter70095-0801cac4b2a-7762-4cbd-b9ab-28c9929a7aa112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-080ERIBULIN MESYLATE INJECTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]1Current NDC, 2 package rows20250515_2c0e145b-96b0-4f7b-8993-0f5f59afa81d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN2c0e145b-96b0-4f7b-8993-0f5f59afa81d1
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD2c0e145b-96b0-4f7b-8993-0f5f59afa81d1
1045456eribulin mesylate 1 MG per 2 ML InjectionSY2c0e145b-96b0-4f7b-8993-0f5f59afa81d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70095-080-01700950080011 VIAL, SINGLE-DOSE in 1 CARTON (70095-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE2025-05-15NoNoCurrent