Pemetrexed
These highlights do not include all the information needed to use PEMETREXED INJECTION safely and effectively. See full prescribing information for PEMETREXED INJECTION. PEMETREXED INJECTION, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
fe432994-e61b-4a87-8c98-cc20b847d0fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2023
Manufacturers
FDA
SHILPA MEDICARE LIMITED
DUNS: 858360192
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pemetrexed disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63759-3049
Application NumberNDA215179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 3, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 500 mg in 50 mL
Code: F4GSH45R4C
Classification: ACTIB
Pemetrexed disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63759-3050
Application NumberNDA215179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 3, 2023
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 1000 mg in 100 mL
Code: F4GSH45R4C
Classification: ACTIB
Pemetrexed disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63759-3048
Application NumberNDA215179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 3, 2023
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED DISODIUM HEMIPENTAHYDRATEActive
Quantity: 100 mg in 10 mL
Code: F4GSH45R4C
Classification: ACTIB