TEMODAR

Products7

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

Product Details

NDC Product Code

0085-3004

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 3 mg in 1 1

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 5 mg in 1 1

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 132.8 mg in 1 1

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 7.5 mg in 1 1

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.2 mg in 1 1

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 1.5 mg in 1 1

shellacInactive

Code: 46N107B71OClass: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

alcoholInactive

Code: 3K9958V90MClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

ammoniaInactive

Code: 5138Q19F1XClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

FD&C Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

TEMODAR

Product Details

NDC Product Code

0085-1381

Application Number

NDA022277

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

September 14, 2023

Ingredients

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 3 mg in 1 mL

threonineInactive

Code: 2ZD004190SClass: IACTQuantity: 4 mg in 1 mL

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACTQuantity: 5.9 mg in 1 mL

mannitolInactive

Code: 3OWL53L36AClass: IACTQuantity: 15 mg in 1 mL

hydrochloric acidInactive

Code: QTT17582CBClass: IACTQuantity: 4 mg in 1 mL

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 2.5 mg in 1 mL

TEMODAR

Product Details

NDC Product Code

0085-1417

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.7 mg in 1 1

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 9 mg in 1 1

shellacInactive

Code: 46N107B71OClass: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 154.3 mg in 1 1

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 22.5 mg in 1 1

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 13.5 mg in 1 1

alcoholInactive

Code: 3K9958V90MClass: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

ammoniaInactive

Code: 5138Q19F1XClass: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 250 mg in 1 1

TEMODAR

Product Details

NDC Product Code

0085-1519

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 182.2 mg in 1 1

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 20 mg in 1 1

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.2 mg in 1 1

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 11 mg in 1 1

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 2.2 mg in 1 1

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 4.4 mg in 1 1

alcoholInactive

Code: 3K9958V90MClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

ammoniaInactive

Code: 5138Q19F1XClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

TEMODAR

Product Details

NDC Product Code

0085-1366

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 100 mg in 1 1

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 175.7 mg in 1 1

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 15 mg in 1 1

shellacInactive

Code: 46N107B71OClass: IACT

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 3 mg in 1 1

alcoholInactive

Code: 3K9958V90MClass: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

ammoniaInactive

Code: 5138Q19F1XClass: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.3 mg in 1 1

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 6 mg in 1 1

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

TEMODAR

Product Details

NDC Product Code

0085-1425

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 140 mg in 1 1

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 246 mg in 1 1

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.4 mg in 1 1

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 4.2 mg in 1 1

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 8.4 mg in 1 1

alcoholInactive

Code: 3K9958V90MClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 21 mg in 1 1

ammoniaInactive

Code: 5138Q19F1XClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

TEMODAR

Product Details

NDC Product Code

0085-1430

Application Number

NDA021029

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 14, 2023

Ingredients

TemozolomideActive

Code: YF1K15M17YClass: ACTIBQuantity: 180 mg in 1 1

anhydrous lactoseInactive

Code: 3SY5LH9PMKClass: IACTQuantity: 316.3 mg in 1 1

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACTQuantity: 0.5 mg in 1 1

tartaric acidInactive

Code: W4888I119HClass: IACTQuantity: 5.4 mg in 1 1

shellacInactive

Code: 46N107B71OClass: IACT

alcoholInactive

Code: 3K9958V90MClass: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

sodium starch glycolate type A potatoInactive

Code: 5856J3G2A2Class: IACTQuantity: 27 mg in 1 1

stearic acidInactive

Code: 4ELV7Z65APClass: IACTQuantity: 10.8 mg in 1 1

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

ammoniaInactive

Code: 5138Q19F1XClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

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