TEMOZOLOMIDE

Basic Information

Product Name

TEMOZOLOMIDE

FDA Product Code

59923-713

Regulatory Information

NDC Product Code

59923-713

Application Number

ANDA204639

Marketing Category

C73584

Effective Date

February 2, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TARTARIC ACID

Code: W4888I119H

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

TEMOZOLOMIDE

Quantity: 250 mg in 1 1

Code: YF1K15M17Y

Class Code: ACTIB

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

Code: YF1K15M17Y

TEMOZOLOMIDE

Basic Information

Regulatory Information

Company Information

Active Ingredients

PROPYLENE GLYCOL

TARTARIC ACID

SILICON DIOXIDE

WATER

STEARIC ACID

GELATIN

ANHYDROUS LACTOSE

POTASSIUM HYDROXIDE

TITANIUM DIOXIDE

FERROSOFERRIC OXIDE

AMMONIA

SODIUM STARCH GLYCOLATE TYPE A POTATO

SHELLAC

Active Moieties

TEMOZOLOMIDE