Eribulin Mesylate

Product NDC
0781-3391
11-digit product format
007813391
Labeler code
0781
Product ID
0781-3391_d122f0a4-aff7-49f7-8cf1-06bc2883ad43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA214310
Marketing category
ANDA
Marketing start
2025-07-07
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
AV9U0660CWERIBULIN MESYLATE441045-17-6ERIBULIN MESYLATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3391-94007813391941 VIAL in 1 CARTON (0781-3391-94) / 2 mL in 1 VIAL1 vial2025-07-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Eribulin MesylateSandoz Inc2024-10-02HUMAN PRESCRIPTION DRUG LABEL1