Basic Information
Temozolomide
65162-805
Regulatory Information
65162-805
ANDA203691
C73584
February 17, 2024
USA
These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 1999
HUMAN PRESCRIPTION DRUG LABEL
25
Company Information
123797875
Active Ingredients
Inactive Ingredients
ANHYDROUS LACTOSE
Code: 3SY5LH9PMK
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
TARTARIC ACID
Code: W4888I119H
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
Active Moieties
TEMOZOLOMIDE
Code: YF1K15M17Y