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TEMODAR

These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) CapsulesTEMODAR (temozolomide) for Injection administered via intravenous infusionInitial U.S. Approval: 1999

Approved
Approval ID

819571ea-b808-4fd8-93c7-1ea2e33d71cf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 9, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 5

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 Code54868-5354
Application NumberNDA021029
Product Classification
M
Marketing Category
C73594
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification

INGREDIENTS (18)

TemozolomideActive
Quantity: 250 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT

Temozolomide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4142
Application NumberNDA021029
Product Classification
M
Marketing Category
C73594
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification

INGREDIENTS (18)

TemozolomideActive
Quantity: 20 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
alcoholInactive
Code: 3K9958V90M
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
waterInactive
Code: 059QF0KO0R
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
gelatinInactive
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 Code54868-5348
Application NumberNDA021029
Product Classification
M
Marketing Category
C73594
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification

INGREDIENTS (20)

anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TemozolomideActive
Quantity: 5 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
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 Code54868-5980
Application NumberNDA021029
Product Classification
M
Marketing Category
C73594
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification

INGREDIENTS (19)

anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
TemozolomideActive
Quantity: 180 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
shellacInactive
Code: 46N107B71O
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
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 Code54868-5350
Application NumberNDA021029
Product Classification
M
Marketing Category
C73594
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification

INGREDIENTS (18)

TemozolomideActive
Quantity: 100 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
tartaric acidInactive
Code: W4888I119H
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT

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TEMODAR - FDA Drug Approval Details