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, USP, for oral use Initial U.S. Approval: 1999

Approved

Approval ID

5543dadb-9812-43d9-a899-ef875b9b1558

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2025

Manufacturers

FDA

NextSource Biotechnology LLC

DUNS: 078779322

Products 4

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 Code58181-4331

Application NumberANDA203898

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateApril 1, 2025

FDA Product Classification

INGREDIENTS (17)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4D

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 140 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58181-4351

Application NumberANDA203898

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateApril 1, 2025

FDA Product Classification

INGREDIENTS (16)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4D

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 250 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58181-4341

Application NumberANDA203898

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateApril 1, 2025

FDA Product Classification

INGREDIENTS (18)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4D

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 180 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58181-4321

Application NumberANDA203898

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateApril 1, 2025

FDA Product Classification

INGREDIENTS (18)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4D

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 100 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

AI-Powered Research

Premium Access

Temozolomide

Products 4

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

MedPath

Product

Company

Legal