FDA.reportPublic FDA data

ERIBULIN MESYLATE

Product NDC
68462-770
11-digit product format
684620770
Labeler code
68462
Product ID
68462-770_ea76510b-f764-478c-b6c4-cdc955a6276b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA218142
Marketing category
ANDA
Marketing start
2025-08-05
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
A218142-001ERIBULIN MESYLATEERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218142-001AP

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 UTC2026-02A218142-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218142-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218142-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-08-056a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218142-001ERIBULIN MESYLATE1MG/2ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2025-08-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218142-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218142-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218142-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218142-001AP1a50c72e98297…

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
55f4017d-5ea8-4622-bf59-9b9c329097fdAvailable 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
68462-770-20ERIBULIN MESYLATE1 in 1 CARTONINJECTION12
68462-770-20ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-770-20ML - Milliliter68462-770ff5504cb-9bf4-438a-9987-0507d72264e412025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERIBULIN MESYLATEERIBULIN MESYLATEGLENMARK PHARMACEUTICALS INC., USA55f4017d-5ea8-4622-bf59-9b9c329097fd2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218142
application number: ANDA218142
ndc (product): 68462-770
ERIBULIN MESYLATEERIBULIN MESYLATEKindos Pharmaceuticals Co., Ltd.9bfd8ac7-57e2-4c9d-add8-26502cfb54a82025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218142
application number: ANDA218142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSN55f4017d-5ea8-4622-bf59-9b9c329097fd2
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCD55f4017d-5ea8-4622-bf59-9b9c329097fd2
1045456eribulin mesylate 1 MG per 2 ML InjectionSY55f4017d-5ea8-4622-bf59-9b9c329097fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-770-20684620770201 VIAL, SINGLE-DOSE in 1 CARTON (68462-770-20) / 2 mL in 1 VIAL, SINGLE-DOSE2025-08-05NoNoCurrent