Temozolomide
These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES, USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES, USP. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999
Approved
Approval ID
33d67bce-38ae-45fc-a858-d51167b0ecfd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2023
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-538
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 20 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Temozolomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-542
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 250 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Temozolomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-540
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
TEMOZOLOMIDEActive
Quantity: 140 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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 Code67877-539
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
TEMOZOLOMIDEActive
Quantity: 100 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Temozolomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-541
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (9)
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TEMOZOLOMIDEActive
Quantity: 180 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Temozolomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-537
Application NumberANDA207658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Temozolomide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (10)
TEMOZOLOMIDEActive
Quantity: 5 mg in 1 1
Code: YF1K15M17Y
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT