Pemetrexed
These highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004
Approved
Approval ID
737ead51-f73c-414f-b68f-d3affc27a225
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-381
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 106 mg in 4 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 100 mg in 4 mL
Code: F4GSH45R4C
Classification: ACTIM
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-382
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 500 mg in 20 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 500 mg in 20 mL
Code: F4GSH45R4C
Classification: ACTIM
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-383
Application NumberANDA214632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Quantity: 1000 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 1000 mg in 40 mL
Code: F4GSH45R4C
Classification: ACTIM