Entecavir Tablet
Product Images NDC 61442-311

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Entecavir (NDC 61442-311). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Carlsbad Technology, 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

Entecavir Tablet_0.5mg_222_30ct (Entecavir Tablet 0.5mg 222 30ct)

Label for Entecavir 0.5 mg oral tablets, manufactured by Carlsbad Technology, Inc. The package contains 30 tablets. The label includes storage instructions (25°C, excursions 15-30°C), light protection, and mentions accompanying package insert for dosage information. NDC 61442-311-30 is displayed with barcode.*

FDA Label Image

Table 10 (Table 10 Entecavir Insert)

A data table titled 'Selected Virologic, Biochemical, and Serologic Endpoints at Week 48, Nucleoside-Inhibitor-Naive Subjects in Studies AI463022 and AI463027,' comparing Entecavir 0.5 mg and Lamivudine 100 mg in HBeAg-positive and HBeAg-negative subjects. It presents endpoints including HBV DNA proportion undetectable, mean change from baseline, ALT normalization, and HBeAg seroconversion.*

FDA Label Image

Table 11 (Table 11 Entecavir Insert)

A table showing histologic improvement and change in Ishak fibrosis scores at week 48 for entecavir 1 mg and lamivudine 100 mg in lamivudine-refractory subjects. The table reports percentages for improvement, no improvement, no change, worsening, and missing week 48 biopsy in both treatment groups.*

FDA Label Image

Table 12 (Table 12 Entecavir Insert)

A data table titled 'Selected Virologic, Biochemical, and Serologic Endpoints at Week 48, Lamivudine-Refractory Subjects in Study AI463026' comparing Entecavir 1 mg (n=141) and Lamivudine 100 mg (n=145) on HBV DNA suppression, ALT normalization, and HBeAg seroconversion outcomes.*

FDA Label Image

Table 13 (Table 13 Entecavir Insert)

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

FDA Label Image

Table 14 (Table 14 Entecavir Insert)

Table presenting virologic and biochemical endpoints at Week 24 from study AI463038 comparing Entecavir 1 mg and placebo. It includes data on HBV DNA proportion undetectable, mean change from baseline in log copies/mL, and ALT normalization percentages for subjects.*

FDA Label Image

Table 3 (Table 3 Entecavir Insert)

A data table summarizing clinical adverse reactions of moderate to severe intensity reported in four entecavir clinical trials over two years. It compares adverse reaction rates for Entecavir 0.5 mg and 1 mg versus Lamivudine 100 mg in nucleoside-inhibitor-naive and lamivudine-refractory patients across gastrointestinal, general, nervous system, and psychiatric categories.*

FDA Label Image

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 percentages of various lab abnormalities such as ALT elevation, albumin levels, bilirubin, lipase, creatinine, hyperglycemia, glycosuria, hematuria, and platelet counts among patient groups treated with Entecavir 0.5 mg and 1 mg versus Lamivudine 100 mg, categorized as Nucleoside-Inhibitor-Naive and Lamivudine-Refractory.*

FDA Label Image

Table 9 (Table 9 Entecavir Insert)

A data table presenting histologic improvement and changes in Ishak Fibrosis Score at Week 48 for nucleoside-inhibitor-naïve subjects in two studies (AI463022 and AI463027), comparing Entecavir 0.5 mg with Lamivudine 100 mg. The table shows percentages of improvement, no improvement, and worsening in Knodell Scores and Ishak Fibrosis Scores across HBeAg-positive and HBeAg-negative groups.*

FDA Label Image

Structural Formula (Structural Formula Entecavir)

Chemical structure diagram of the active ingredient entecavir, showing its molecular configuration with labeled atoms and groups, including hydroxyl groups and a purine derivative base, as well as an associated water molecule (hydrate).*

* 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.