Pemetrexed disodium
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
e4a92d35-a0ac-486e-94a7-289ede47af46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
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 Code70121-1232
Application NumberANDA210047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 11, 2022
FDA Product Classification
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 100 mg in 10 mL
Code: 2PKU919BA9
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Quantity: 106 mg in 10 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Pemetrexed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1233
Application NumberANDA210047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 11, 2022
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Quantity: 500 mg in 20 mL
Code: 3OWL53L36A
Classification: IACT
PEMETREXED DISODIUMActive
Quantity: 500 mg in 20 mL
Code: 2PKU919BA9
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT