Temozolomide Capsule
Product Images NDC 16729-130

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Temozolomide (NDC 16729-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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 (Temo 100mg 5cap Amber Cart)

Packaging label for Temozolomide 100 mg capsules USP, prescription drug by Accord Healthcare Inc. The unfolded carton includes product name, strength, dosage form, NDC 16729-050-53, quantity of 5 capsules, and manufacturer information for Accord Healthcare, Inc. and Intas Pharmaceuticals Limited. Label contains warnings, storage instructions, and barcode.*

FDA Label Image

Temo 100mg 5cap Sachet Cart

Temozolomide Capsules USP 100 mg carton label for oral capsules by Accord Healthcare Inc. The package contains 5 individual sachets, each with one 100 mg capsule. The label includes a caution about cytotoxic handling, storage instructions at 25°C, and manufacturing information from Intas Pharmaceuticals Limited, India.*

FDA Label Image

Principal Display Panel (Temo 140mg 5cap Amber Cart)

Packaging label for Temozolomide Capsules USP, 140 mg strength, manufactured by Intas Pharmaceuticals Limited and labeled by Accord Healthcare Inc. The label indicates Rx only, contains 5 capsules, and provides cautions about handling the cytotoxic capsules. Storage instructions specify maintaining 25°C (77°F) with permissible excursions and dispensing in light-resistant containers.*

FDA Label Image

Temo 140mg 5cap Sachet Cart

Packaging label for Temozolomide Capsules USP 140 mg, an oral prescription drug by Accord Healthcare Inc. The label includes the NDC 16729-129-31 and states that the package contains 5 individual sachets, each with one capsule. The label cautions about cytotoxicity, instructs to swallow capsules whole, and provides storage recommendations.*

FDA Label Image

Principal Display Panel (Temo 180mg 5cap Amber Cart)

Temozolomide 180 mg capsules USP carton for oral use, Rx only, manufactured for Accord Healthcare Inc. The label indicates 5 capsules per package. The packaging warns that capsules are cytotoxic and must be swallowed whole, with storage instructions at controlled room temperature. Manufactured by Intas Pharmaceuticals Limited, India.*

FDA Label Image

Temo 180mg 5cap Sachet Cart

Packaging label for Temozolomide Capsules USP 180 mg by Accord Healthcare Inc. The label indicates the product is prescription only, with a package containing 5 individual sachets, each holding one capsule. Important handling and storage information is included, along with manufacturer details for Accord Healthcare and Intas Pharmaceuticals in India.*

FDA Label Image

Principal Display Panel (Temo 20mg 5cap Amber Cart)

Packaging label for Temozolomide Capsules USP 20 mg by Accord Healthcare Inc. The carton includes 5 capsules, with an NDC of 16729-049-53. It features warnings and storage instructions, indicating the medication should be stored at 25°C (77°F) and dispensed in tight, light-resistant containers. The label also advises not to open capsules and to swallow them whole.*

FDA Label Image

Temo 20mg 5cap Sachet Cart

Packaging label for Temozolomide Capsules USP 20 mg from Accord Healthcare Inc. The label states prescription use only and indicates the package contains 5 individual sachets, each with one capsule. It includes storage instructions, a cytotoxic warning, barcode, and manufacturer details.*

FDA Label Image

Principal Display Panel (Temo 250mg 5cap Amber Cart)

Packaging label for Temozolomide capsules USP 250 mg, manufactured by Intas Pharmaceuticals Limited and labeled by Accord Healthcare Inc. The carton contains 5 capsules. The label includes warnings about cytotoxicity, storage instructions, and advises pharmacists to review special dispensing information carefully.*

FDA Label Image

Temo 250mg 5cap Sachet Cart

Packaging label for Temozolomide Capsules USP, 250 mg strength, from Accord Healthcare Inc. The label indicates the product is for prescription use only and contains 5 individual sachets, each with one capsule. Additional information includes manufacturer details, storage instructions, and warnings related to the cytotoxic nature of the capsules.*

FDA Label Image

Principal Display Panel (Temo 5mg 5cap Amber Cart)

Packaging label for Temozolomide Capsules USP, 5 mg strength. The label indicates it is a prescription drug (Rx Only) and contains 5 capsules. Manufactured for Accord Healthcare Inc. with manufacturing by Intas Pharmaceuticals Limited, India. The label includes handling precautions and storage instructions, stating the capsules should be stored at 25°C (77°F) with permitted excursions and kept in tight, light-resistant containers.*

FDA Label Image

Temo 5mg 5cap Sachet Cart

Temozolomide 5 mg Capsules USP packaging label for oral capsules by Accord Healthcare Inc. The label states Rx only and indicates the package contains 5 individual sachets, each containing one capsule. It includes storage instructions, cytotoxic warnings, and manufacturer information with barcodes on multiple panels.*

FDA Label Image

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

A Kaplan-Meier survival curve chart titled 'ITT Population: Overall Survival' showing overall survival probability over time in months from randomization. It compares two groups: RT+TMZ (radiotherapy plus temozolomide) with a higher survival probability curve versus RT Only, using survival probability on the y-axis and time in months on the x-axis, with an indicated hazard ratio and statistical significance values.*

FDA Label Image

Chemical Structure (Temo Structure)

Chemical structure of temozolomide, showing its molecular arrangement with characteristic nitrogen and oxygen atoms, including a methyl group and an amide functional group.*

FDA Label Image

Table 1 (Temo Table 1)

A dosing modification flowchart titled 'Dosing Modification Table for Refractory Anaplastic Astrocytoma' outlining dose adjustment steps for a chemotherapy regimen starting at 150 or 200 mg/m²/day for 5 days. It guides measurement of ANC and platelets on days 22 and 29, with subsequent dose changes based on lowest counts at either day, detailing thresholds for ANC and platelet counts and corresponding actions such as postponing therapy or increasing/maintaining dose for the next cycle.*

* 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.