FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214310-001ERIBULIN MESYLATEERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214310-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214310-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214310-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214310-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-06-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214310-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214310-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214310-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214310-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214310-001AP1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AV9U0660CWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1045456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d122f0a4-aff7-49f7-8cf1-06bc2883ad43Available on FDA.report

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
0781-3391-94Eribulin Mesylate2 mL in 1 VIALINJECTION21
0781-3391-94Eribulin Mesylate1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3391-94ML - Milliliter0781-3391a8f7cd17-71e2-4502-ab42-ef777fd3e2a112025-07-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eribulin MesylateERIBULIN MESYLATESandoz Incd122f0a4-aff7-49f7-8cf1-06bc2883ad432024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214310
application number: ANDA214310
ndc (product): 0781-3391

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSNd122f0a4-aff7-49f7-8cf1-06bc2883ad431
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCDd122f0a4-aff7-49f7-8cf1-06bc2883ad431
1045456eribulin mesylate 1 MG per 2 ML InjectionSYd122f0a4-aff7-49f7-8cf1-06bc2883ad431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3391-94007813391941 VIAL in 1 CARTON (0781-3391-94) / 2 mL in 1 VIAL1 vial2025-07-07NoNoCurrent