Halaven Injection
Product Images NDC 62856-389

5 FDA label images from Eisai Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Halaven (NDC 62856-389). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eisai Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

A Product Isolated From The Marine Sponge Halichondria Okadai. The Chemical Name For Eribulin Mesylate Is 11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4h)-one, 2-[(2s)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2r,3r,3as,7r,8as,9s,10ar,11s,12r,13ar,13bs,15s,18s,21s,24s,26r,28r,29as)-, Methanesulfonate (salt). It Has A Molecular Weight Of 826.0 (729.9 For Free Base). The Empirical Formula Is C40h59no11•ch4o3s. Eribulin Mesylate Has The Following Structural Formula: (Halaven 01)

A Product Isolated From The Marine Sponge Halichondria Okadai.  The Chemical Name For Eribulin Mesylate Is 11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4h)-one, 2-[(2s)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2r,3r,3as,7r,8as,9s,10ar,11s,12r,13ar,13bs,15s,18s,21s,24s,26r,28r,29as)-, Methanesulfonate (salt).  It Has A Molecular Weight Of 826.0 (729.9 For Free Base).  The Empirical Formula Is C40h59no11•ch4o3s.  Eribulin Mesylate Has The Following Structural Formula: (Halaven 01)
Chemical structure diagram of eribulin mesylate, the active ingredient in Halaven injection 0.5 mg/mL. The structure shows multiple ring systems, oxygen, nitrogen atoms, and functional groups characteristic of this complex molecule.*
FDA Label Image

Figure 1: Updated Overall Survival Analysis For Study 1 (Halaven 02)

Figure 1:  Updated Overall Survival Analysis For Study 1 (Halaven 02)
A Kaplan-Meier survival curve comparing proportion of patients alive over time (months) between Halaven (eribulin mesylate) treated group (N=508) and control group (N=254). The chart includes patient numbers at risk at various time points up to 36 months.*
FDA Label Image

Kaplan-meier Curves Of Overall Survival In The Liposarcoma Stratum In Study 2 (Halaven 03)

Kaplan-meier Curves Of Overall Survival In The Liposarcoma Stratum In Study 2 (Halaven 03)
A survival curve chart comparing the survival probability over time (in months) between Halaven and Dacarbazine. The chart features two lines, a solid blue line for Halaven and a dashed red line for Dacarbazine, tracking survival probability from 0 to 42 months. A table below the graph shows subjects at risk for each group at various time points.*
FDA Label Image

Ndc 62856-389-01halaven™(eribulin Mesylate) Injection1 mg/2 mL(0.5 mg/ml)for Intravenous Use (Halaven 04)

Ndc 62856-389-01halaven™(eribulin Mesylate) Injection1 mg/2 mL(0.5 mg/ml)for Intravenous Use (Halaven 04)
Halaven (eribulin mesylate) Injection 1 mg/2 mL (0.5 mg/mL) single-dose vial carton label for intravenous use. The sterile solution is distributed by Eisai Inc. and is labeled for Rx only. The packaging includes storage instructions and cautions.*
FDA Label Image

Halaven 05

Halaven 05
Halaven (eribulin mesylate) Injection label for 1 mg/2 mL (0.5 mg/mL) sterile solution. The label includes storage instructions to keep at 25°C with allowed excursions, a caution that it is a cytotoxic agent, and directions to discard unused portions from the single-dose vial. Distributed by Eisai Inc., Nutley, NJ, made in Japan.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.