Temozolomide Capsule
Product Images NDC 16571-821

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Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Temozolomide (NDC 16571-821). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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

100-mg (100 mg)

100-mg (100 mg)
Each capsule of NDC 16571-818-51 contains 100mg of Temozolomide, USP which is a cytotoxic agent manufactured by Rising Pharma Holdings, Inc. The package insert includes recommendations for the appropriate use of Temozolomide varying capsule strengths in Capsules, USP to establish a daily regimen. The drug should be dispensed in tight, light-resistant containers as defined in USP/NF, and should be stored at 25°C (77°F) with allowed excursions to 15° to 30°C (59° to 86°F). The accompanying directions should be read fully before use. Made in India.*
FDA Label Image

140-mg (140 mg)

140-mg (140 mg)
This is a description of a medication with the NDC code 16571-819-51 containing 140mg of Temozolomide, manufactured by Rising Pharma Holdings, Inc. in East Brunswick, NJ. The recommended dosage is not provided, but can be found in the package insert. It is a cytotoxic agent and should be administered orally with caution. It should be stored in tight, light-resistant containers at room temperature. It has been manufactured in India and the packaging has a Code: TS/DRUGS/24/2015 and was issued in April 2022.*
FDA Label Image

180-mg (180 mg)

180-mg (180 mg)
This is a description of a medication with the NDC code 16571-820-51, which contains 180mg of Temozolomide, a cytotoxic agent used for cancer treatment. It is manufactured by Rising Pharma Holdings, Inc. and dispensed in capsules, USP. The usual dose is to be determined by following the package insert guidelines. The directions for administration should be carefully followed, and caution should be exercised as it is a cytotoxic agent. It should be stored in tight, light-resistant containers between 15°C to 30°C (59°F to 86°F). The text also includes other technical information such as code, issuance date, and controlled room temperature guidelines.*
FDA Label Image

20-mg (20 mg)

20-mg (20 mg)
Each capsule of 'Rising' NDC 16571-817-51 contains 20 mg of Temozolomide, a cytotoxic agent used in establishing a daily regimen. The package insert provides recommendations for the use of varying capsule strengths. The capsules should be dispensed in tight, light-resistant containers as defined in USP/NF and stored at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). Read accompanying directions carefully before using this product.*
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250-mg (250 mg)

250-mg (250 mg)
This is a description of medication, Temozolomide capsules used for oral administration which is a cytotoxic agent requiring special handling. Each capsule contains 250 mg of Temozolomide, USP. The usual dose is mentioned in the package insert. This medication should be dispensed in tight, light-resistant containers and stored at a controlled room temperature. The manufacturing company is Rising Pharma Holdings located in East Brunswick, NJ.*
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5-mg (5 mg)

5-mg (5 mg)
Each capsule of PERising woc16571-816-51 contains 5 mg Tamozolomids, USP pharmaceutical ingredient. The medication is manufactured by Rising Pharma Holdings Inc., located in East Brunswick, NJ 08816. It is a cytotoxic agent, and caution must be taken while handling and storing it. The medication is dispensed for oral administration, and it is contained in special vessels according to the United States Pharmacopeia/ National Formulary guidelines. The container must be stored between 15 to 30°C, with a specified permitted range of temperature excursions, and must be protected from light. Further information about administration and dosage can be found in the package insert.*
FDA Label Image

Figure 1 (Figure 01)

Figure 1 (Figure 01)
This appears to be a statistical analysis output for a clinical trial. The ITT population (which likely stands for "intent-to-treat") is being evaluated for overall survival. The hazard ratio (HR) is 0.63 with a confidence interval of 0.52 to 0.75, and the log-rank P-value is less than 0.0001. The numbers 12, 16, 220, 2, 28, 32, and 36 likely correspond to some sort of time intervals.*
FDA Label Image

Structural Formula (Structural Formula)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.