Temozolomide

for oral use

Approved

Approval ID

bd3eae4f-7294-4a42-b726-34193d6ba753

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2016

Manufacturers

FDA

Lannett Company, Inc.

DUNS: 002277481

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 Code0527-1780

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (20)

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 140 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1779

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (20)

TEMOZOLOMIDEActive

Quantity: 100 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1781

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (20)

TEMOZOLOMIDEActive

Quantity: 180 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1782

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (20)

TEMOZOLOMIDEActive

Quantity: 250 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1777

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (21)

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TEMOZOLOMIDEActive

Quantity: 5 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1778

Application NumberANDA202750

Product Classification

Marketing Category

C73584

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateDecember 1, 2015

FDA Product Classification

INGREDIENTS (22)

TEMOZOLOMIDEActive

Quantity: 20 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

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Temozolomide

Products 6

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

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