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
3ae68628-7ab0-4491-b3ae-6a8330b719c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-2188
Application NumberNDA214218
Product Classification
M
Marketing Category
C73594
G
Generic Name
PEMETREXED
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 500 mg in 20 mL
Code: 2PKU919BA9
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1045
Application NumberNDA214218
Product Classification
M
Marketing Category
C73594
G
Generic Name
PEMETREXED
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 100 mg in 4 mL
Code: 2PKU919BA9
Classification: ACTIM
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-3532
Application NumberNDA214218
Product Classification
M
Marketing Category
C73594
G
Generic Name
PEMETREXED
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (4)
PEMETREXED DISODIUMActive
Quantity: 1 g in 40 mL
Code: 2PKU919BA9
Classification: ACTIM
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT