Oxcarbazepine
Product Images NDC 21695-862

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Oxcarbazepine (NDC 21695-862). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, 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

Structural Formula Of Oxcarbazepine (E8a485af A78b 49a0 9bf4 75e1cd5bb740 01)

Chemical structure of oxcarbazepine showing a dibenzazepine ring system with a ketone group and an amide substituent.*

FDA Label Image

Figure 1 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 02)

A Kaplan-Meier survival curve chart illustrating the exit rate over time on trial from Day 2 to Day 11 for two treatment groups: Oxcarbazepine and Placebo. The solid line represents the Oxcarbazepine group, and the dotted line represents the Placebo group. The chart includes a p-value from a log-rank test showing statistical comparison between groups.*

FDA Label Image

Figure 2 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 03)

A Kaplan-Meier curve chart showing seizure rate over days from first dose to first seizure for two treatment groups: Oxcarbazepine and Placebo. The x-axis represents days while the y-axis represents seizure rate. The chart includes a log-rank test p-value of 0.046 comparing the groups.*

FDA Label Image

Figure 3 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 04)

A Kaplan-Meier plot showing exit rate over time in days for two treatment groups labeled as HIGH (solid line) and LOW (dashed line). The chart includes a log-rank test p-value of 0.0001, indicating a statistical comparison between the two groups' exit rates across the observed period up to 130 days.*

FDA Label Image

Figure 4 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 05)

A Kaplan-Meier survival curve chart depicting time to exit (days) on the x-axis and exit rate on the y-axis. It compares two treatment groups labeled HIGH (solid line) and LOW (dotted line), with a log-rank test p-value of 0.0001 indicating statistical significance.*

FDA Label Image

Table 3 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 06)

A data table showing the influence of oxcarbazepine on the concentration of other antiepileptic drugs (AED) and vice versa. It includes AEDs coadministered (Carbamazepine, Phenobarbital, Phenytoin, Valproic acid), their doses in mg/day, oxcarbazepine dose in mg/day, and mean percentage changes with 90% confidence intervals for AED and metabolite concentrations.*

FDA Label Image

Table 4 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 07)

A table presenting adverse event percentages across various body systems for Oxcarbazepine at dosages of 600 mg/day, 1200 mg/day, and 2400 mg/day, compared to placebo. It includes categories like Body as a Whole, Cardiovascular, Digestive, Metabolic, Musculoskeletal, Nervous, Respiratory, Skin, and Special Senses.*

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Table 5 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 08)

A data table listing adverse events by body system associated with Oxcarbazepine dosage levels of 2400 mg/day and 300 mg/day. It details the percentage incidence of various side effects across categories like Body as a Whole, Digestive System, Nervous System, Respiratory System, Skin and Appendages, Special Senses, and Urogenital and Reproductive System for a sample size of 86 subjects at each dosage.*

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Table 6 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 09)

A table presenting the percentage of subjects experiencing various adverse events by body system for Oxcarbazepine (N=55) compared to placebo (N=49). It lists events in systems including digestive, musculoskeletal, nervous, respiratory, skin, and special senses, with specific symptoms such as nausea, dizziness, headache, and rash.*

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Table 7 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 10)

A data table comparing adverse events by body system in subjects receiving Oxcarbazepine (N=171) versus placebo (N=139). It lists percentages for events across categories: Body as a Whole, Digestive System, Nervous System, Respiratory System, Skin and Appendages, and Special Senses, highlighting higher rates in Oxcarbazepine groups for symptoms like fatigue, vomiting, headache, somnolence, dizziness, diplopia, and vision abnormalities.*

FDA Label Image

Table 8 (E8a485af A78b 49a0 9bf4 75e1cd5bb740 11)

A dosing guideline table for Oxcarbazepine showing weight in kilograms alongside corresponding dose ranges in milligrams per day. It lists weight values from 20 kg to 70 kg and the associated minimum ('From') and maximum ('To') daily doses in mg.*

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Glenmark Logo (E8a485af A78b 49a0 9bf4 75e1cd5bb740 12)

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Oxcarbazepine 300mg (E8a485af A78b 49a0 9bf4 75e1cd5bb740 13)

Oxcarbazepine 300 mg tablets label showing a package of 60 film-coated, yellow, biconvex oval tablets. The label includes details such as lot number, expiration date, and Product ID PO086360CA. It indicates packaging by Physician Partner and manufacturing by Glenmark Generics LTD, Goa, India. Storage instructions and RX only status are also present.*

* 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.