Pralatrexate
These highlights do not include all the information needed to use PRALATREXATE INJECTION safely and effectively. See full prescribing information for PRALATREXATE INJECTION.PRALATREXATE injection, for intravenous useInitial U.S. Approval: 2009
Approved
Approval ID
a5daa583-4965-4564-ad87-41ffe6c08a11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pralatrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-550
Application NumberNDA022468
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pralatrexate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2022
FDA Product Classification
INGREDIENTS (5)
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
PralatrexateActive
Quantity: 20 mg in 1 mL
Code: A8Q8I19Q20
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Pralatrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-552
Application NumberNDA022468
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pralatrexate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2022
FDA Product Classification
INGREDIENTS (5)
PralatrexateActive
Quantity: 40 mg in 2 mL
Code: A8Q8I19Q20
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT