TEMODAR

These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) capsules, for oral use TEMODAR (temozolomide) for injection, for intravenous use Initial U.S. Approval: 1999

Approved

Approval ID

046a9011-3911-4d3f-a15f-fbb56d5aad56

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2023

Manufacturers

FDA

Merck Sharp & Dohme LLC

DUNS: 118446553

Products 7

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 Code0085-3004

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (20)

stearic acidInactive

Quantity: 3 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

TemozolomideActive

Quantity: 5 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

anhydrous lactoseInactive

Quantity: 132.8 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 7.5 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

silicon dioxideInactive

Quantity: 0.2 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

tartaric acidInactive

Quantity: 1.5 mg in 1 1

Code: W4888I119H

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

FD&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1381

Application NumberNDA022277

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (6)

polysorbate 80Inactive

Quantity: 3 mg in 1 mL

Code: 6OZP39ZG8H

Classification: IACT

threonineInactive

Quantity: 4 mg in 1 mL

Code: 2ZD004190S

Classification: IACT

trisodium citrate dihydrateInactive

Quantity: 5.9 mg in 1 mL

Code: B22547B95K

Classification: IACT

mannitolInactive

Quantity: 15 mg in 1 mL

Code: 3OWL53L36A

Classification: IACT

hydrochloric acidInactive

Quantity: 4 mg in 1 mL

Code: QTT17582CB

Classification: IACT

TemozolomideActive

Quantity: 2.5 mg in 1 mL

Code: YF1K15M17Y

Classification: ACTIB

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1417

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (18)

silicon dioxideInactive

Quantity: 0.7 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

tartaric acidInactive

Quantity: 9 mg in 1 1

Code: W4888I119H

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

anhydrous lactoseInactive

Quantity: 154.3 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 22.5 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

stearic acidInactive

Quantity: 13.5 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

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

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

TemozolomideActive

Quantity: 250 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1519

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (18)

anhydrous lactoseInactive

Quantity: 182.2 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

TemozolomideActive

Quantity: 20 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

silicon dioxideInactive

Quantity: 0.2 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 11 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

tartaric acidInactive

Quantity: 2.2 mg in 1 1

Code: W4888I119H

Classification: IACT

stearic acidInactive

Quantity: 4.4 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1366

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (18)

TemozolomideActive

Quantity: 100 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

anhydrous lactoseInactive

Quantity: 175.7 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 15 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

tartaric acidInactive

Quantity: 3 mg in 1 1

Code: W4888I119H

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

silicon dioxideInactive

Quantity: 0.3 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

stearic acidInactive

Quantity: 6 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1425

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (18)

TemozolomideActive

Quantity: 140 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

anhydrous lactoseInactive

Quantity: 246 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

silicon dioxideInactive

Quantity: 0.4 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

tartaric acidInactive

Quantity: 4.2 mg in 1 1

Code: W4888I119H

Classification: IACT

stearic acidInactive

Quantity: 8.4 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 21 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0085-1430

Application NumberNDA021029

Product Classification

Marketing Category

C73594

Generic Name

Temozolomide

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 14, 2023

FDA Product Classification

INGREDIENTS (19)

TemozolomideActive

Quantity: 180 mg in 1 1

Code: YF1K15M17Y

Classification: ACTIB

anhydrous lactoseInactive

Quantity: 316.3 mg in 1 1

Code: 3SY5LH9PMK

Classification: IACT

silicon dioxideInactive

Quantity: 0.5 mg in 1 1

Code: ETJ7Z6XBU4

Classification: IACT

tartaric acidInactive

Quantity: 5.4 mg in 1 1

Code: W4888I119H

Classification: IACT

shellacInactive

Code: 46N107B71O

Classification: IACT

alcoholInactive

Code: 3K9958V90M

Classification: IACT

butyl alcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

potassium hydroxideInactive

Code: WZH3C48M4T

Classification: IACT

ferric oxide yellowInactive

Code: EX438O2MRT

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

sodium starch glycolate type A potatoInactive

Quantity: 27 mg in 1 1

Code: 5856J3G2A2

Classification: IACT

stearic acidInactive

Quantity: 10.8 mg in 1 1

Code: 4ELV7Z65AP

Classification: IACT

isopropyl alcoholInactive

Code: ND2M416302

Classification: IACT

ammoniaInactive

Code: 5138Q19F1X

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

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TEMODAR

Products 7

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (6)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Temozolomide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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