Temodar
Product Images NDC 54868-5354

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Temodar (NDC 54868-5354). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, 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

Principal Display Panel (20 mg Capsule)

TEMODAR 20 mg capsules packaging label by Physicians Total Care, Inc. Contains 30 capsules of temozolomide. The label includes dosage information, a caution about federal law prohibiting dispensing without a prescription, and storage instructions. The label also displays the lot number and expiration date.*

FDA Label Image

Principal Display Panel (5 mg Capsule)

TEMODAR 5 mg capsule label distributed by Physicians Total Care, Inc., Tulsa, OK. The label shows NDC 54868-5348-1, quantity of 5 capsules, lot number 0000, and expiration date 01/60. Manufactured by Schering Corporation, Kenilworth, NJ. Includes a barcode with code 53480050000.*

FDA Label Image

Principal Display Panel (100 mg Capsule)

Packaging label of TEMODAR 100 mg capsules by Physicians Total Care, Inc. The label includes the NDC 54868-5358-4, a caution that federal law prohibits dispensing without a prescription, and a quantity of 30 capsules. Additional information on contents and usage precautions is present alongside a barcode and lot/expiry details.*

FDA Label Image

Principal Display Panel (250 mg Capsule)

TEMODAR 250 mg capsule label showing 5 capsules in the package. Distributed by Physicians Total Care, Inc. in Tulsa, OK. Manufactured by Schering Corporation, Kenilworth, NJ. Lot number and expiration date (01/60) are also visible along with a barcode and the NDC 54868-5354-0.*

FDA Label Image

Principal Display Panel (180 mg Capsule)

Label for TEMODAR 180MG capsules distributed by Physicians Total Care, Inc. The label includes NDC 54868-5980-0, a lot number, expiration date, manufacturer information (Schering Corporation, Kenilworth, NJ), and a barcode. The package contains 14 capsules.*

FDA Label Image

Table 4: Dosing Modification Table (Temodar 01)

A flowchart outlining dosing adjustment steps for TEMODAR based on ANC and platelet counts measured on Days 22 and 29. It guides dose postponement, reduction, or maintenance depending on specific ANC and platelet thresholds over treatment cycles.*

FDA Label Image

Chemical Structure (Temodar 02)

Chemical structure diagram of temozolomide, the active ingredient in TEMODAR. The structure depicts the arrangement of nitrogen, oxygen, carbon, and hydrogen atoms forming the temozolomide molecule.*

FDA Label Image

Figure 1: Kaplan-meier Curves For Overall Survival (itt Population) (Temodar 03)

A survival curve chart titled 'ITT Population: Overall Survival' comparing two groups: RT+TMZ and RT Only. The x-axis shows time from randomization in months, and the y-axis shows survival probability from 0 to 1. The RT+TMZ group shows higher survival probabilities over time compared to RT Only. The chart includes a hazard ratio (HR) of 0.63 with a 95% confidence interval and a log-rank p-value less than 0.0001.*

FDA Label Image

Table (Temodar 04)

A flowchart illustrating the dosing adjustment process for TEMODAR based on absolute neutrophil count (ANC) and platelet levels. It starts with dosing at either 150 mg/m²/day or 200 mg/m²/day for 5 days, followed by measuring ANC and platelets on Day 22 and Day 29. The flowchart provides guidance to postpone therapy or adjust dose according to specific ANC and platelet thresholds for subsequent cycles.*

* 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.