Home NDC 68083-592 eribulin mesylate
Product NDC 68083-592
11-digit product format 680830592
Labeler code 68083
Product ID 68083-592_5db5b24e-3893-4985-a658-731cb840eb76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eribulin mesylate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218047
Marketing category ANDA
Marketing start 2024-04-05
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218047-001 ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218047-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218047-001 ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2024-04-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base eribulin mesylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERIBULIN MESYLATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AV9U0660CW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1045456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-592-01 eribulin mesylate 1 in 1 CARTON INJECTION 1 3 68083-592-01 eribulin mesylate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-592 ERIBULIN MESYLATE INJECTION [GLAND PHARMA LIMITED] 3 Current NDC, 2 package rows 20240413_f57835e2-4c53-4e93-b54b-7d7a5000ae3d.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68083-592-01 68083059201 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2024-04-05 No No Current