Entecavir Tablet
Product Images NDC 51407-589

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Entecavir (NDC 51407-589). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Golden State Medical Supply, 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

51407-589-30ol.jpg (51407 589 30ol)

Label for Entecavir Tablets 0.5 mg by Golden State Medical Supply, Inc. The label includes NDC 51407-589-30 and indicates a package of 30 tablets for oral use. It includes storage instructions, dosing references, and a GSMS Incorporated logo with website information for patient details.*

FDA Label Image

Table 10 (Table 10 Entecavir Insert)

Data table presenting selected virologic, biochemical, and serologic endpoints at week 48 for nucleoside-inhibitor-naive subjects in studies AI463022 and AI463027. It compares outcomes between Entecavir 0.5 mg and Lamivudine 100 mg tablets in HBeAg-positive and HBeAg-negative groups.*

FDA Label Image

Table 11 (Table 11 Entecavir Insert)

A data table titled 'Histologic Improvement and Change in Ishak Fibrosis Score at Week 48, Lamivudine-Refractory Subjects in Study AI463026' comparing Entecavir 1 mg (n=124) and Lamivudine 100 mg (n=116). It presents the percent of subjects with histologic improvement and Ishak fibrosis score changes, including improvement, no change, worsening, and missing biopsy at Week 48.*

FDA Label Image

Table 12 (Table 12 Entecavir Insert)

Data table titled 'Selected Virologic, Biochemical, and Serologic Endpoints at Week 48, Lamivudine-Refractory Subjects in Study AI463026' comparing Entecavir 1 mg and Lamivudine 100 mg, showing HBV DNA undetectable proportions, mean change from baseline, ALT normalization, and HBeAg seroconversion percentages.*

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Table 13 (Table 13 Entecavir Insert)

A data table titled 'Selected Endpoints at Week 48, Subjects with Decompensated Liver Disease, Study AI463048' comparing clinical endpoints between patients treated with Entecavir 1 mg (n=100) and Adefovir Dipivoxil 10 mg (n=91). The table lists proportions for HBV DNA undetectable, stable or improved CTP score, HBsAg loss, and ALT normalization percentages.*

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Table 14 (Table 14 Entecavir Insert)

A data table titled 'Virologic and Biochemical Endpoints at Week 24, Study AI463038' comparing Entecavir 1 mg (n=51) and placebo (n=17). It presents values for HBV DNA (proportion undetectable, mean change from baseline) and ALT normalization percentages for both groups.*

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Table 3 (Table 3 Entecavir Insert)

A data table titled 'Clinical Adverse Reactions of Moderate-Severe Intensity Reported in Four Entecavir Clinical Trials Through 2 Years.' It lists adverse reactions by body system comparing Entecavir 0.5 mg and Lamivudine 100 mg in nucleoside-inhibitor-naïve and lamivudine-refractory patients with corresponding sample sizes. Adverse reactions include gastrointestinal, general, nervous system, and psychiatric effects with percentages reported for each treatment group.*

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Table 4 (Table 4 Entecavir Insert)

A data table titled 'Selected Treatment-Emergent Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years.' It compares laboratory abnormalities in patients treated with Entecavir 0.5 mg and 1 mg versus Lamivudine 100 mg, in nucleoside-inhibitor-naive and Lamivudine-refractory groups. The table lists tests such as ALT, albumin, bilirubin, lipase, creatinine, glycosuria, hematuria, and platelets, with percentages or incidence values for each group.*

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Table 9 (Table 9 Entecavir Insert)

A data table titled 'Histologic Improvement and Change in Ishak Fibrosis Score at Week 48' comparing Entecavir 0.5 mg versus Lamivudine 100 mg in nucleoside-inhibitor-naïve subjects across two studies (HBeAg-Positive and HBeAg-Negative). It shows percentages for histologic improvement, Ishak fibrosis score changes, and missing biopsy data at week 48 for each medication and study group.*

FDA Label Image

Structural Formula (Structural Formula Entecavir)

Chemical structure diagram of Entecavir hydrate showing molecular bonds, hydroxyl groups, and nitrogen atoms typical of this antiviral compound.*

* 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.