Temozolomide

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Lannett Company, Inc.

Labeler

Lannett Company, Inc.

DUNS Number

829757603

Products6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

0527-1780

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 140 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

Temozolomide

Product Details

NDC Product Code

0527-1779

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 100 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Temozolomide

Product Details

NDC Product Code

0527-1781

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 180 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

Temozolomide

Product Details

NDC Product Code

0527-1782

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 250 mg in 1 1

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Temozolomide

Product Details

NDC Product Code

0527-1777

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 5 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

Temozolomide

Product Details

NDC Product Code

0527-1778

Application Number

ANDA202750

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2015

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 20 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

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Temozolomide

FDA Approval Summary

Manufacturing Establishments1

Products6

Temozolomide

Product Details

Temozolomide

Product Details

Temozolomide

Product Details

Temozolomide

Product Details

Temozolomide

Product Details

Temozolomide

Product Details