Temozolomide
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
Approved
Approval ID
c1e05c21-a411-4493-80de-ede373632475
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-891
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (14)
TEMOZOLOMIDEActive
Quantity: 20 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-893
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (15)
TEMOZOLOMIDEActive
Quantity: 250 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-890
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (15)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 5 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-892
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (16)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 100 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-929
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (14)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 140 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Temozolomide
PRODUCT DETAILS
NDC Product Code47335-930
Application NumberANDA201742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2023
Generic NameTemozolomide
INGREDIENTS (14)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 180 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT