This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Temozolomide

Read time: 1 mins
Marketing start date: 23 Nov 2024
...
 

Summary of product characteristics


Effective Time

20221017

Version

5

Spl Product Data Elements

temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER GREEN WHITE CAPSULE 751 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER YELLOW WHITE CAPSULE 752 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ANHYDROUS LACTOSE SODIUM STARCH GLYCOLATE TYPE B POTATO TARTARIC ACID STEARIC ACID BUTYL ALCOHOL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA WATER GELATIN TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 3 D&C YELLOW NO. 10 SILICON DIOXIDE PINK WHITE CAPSULE 753 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER BLUE WHITE CAPSULE 754 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER ORANGE WHITE CAPSULE 755 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER WHITE WHITE CAPSULE 756

Application Number

ANDA206750

Brand Name

Temozolomide

Generic Name

temozolomide

Product Ndc

70771-1093

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1092-6 in bottle of 5 capsules Temozolomide Capsules, 5 mg R x only 5 capsules NDC 70771-1093-6 in bottle of 5 capsules Temozolomide Capsules, 20 mg R x only 5 capsules NDC 70771-1094-6 in bottle of 5 capsules Temozolomide Capsules, 100 mg R x only 5 capsules NDC 70771-1095-6 in bottle of 5 capsules Temozolomide Capsules, 140 mg R x only 5 capsules NDC 70771-1096-6 in bottle of 5 capsules Temozolomide Capsules, 180 mg R x only 5 capsules NDC 70771-1097-6 in bottle of 5 capsules Temozolomide Capsules, 250 mg R x only 5 capsules Temozolomide capsules, 5 mg Temozolomide capsules, 20 mg Temozolomide capsules, 100 mg Temozolomide capsules, 140 mg Temozolomide capsules, 180 mg Temozolomide capsules, 250 mg

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.