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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-891

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-893

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-890

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-892

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-929

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47335-930

Application NumberANDA201742

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 13, 2023

FDA Product Classification

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

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Temozolomide

Products 6

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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