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
1008b3f9-8bf0-b852-e716-f0bffe465906
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
Products 1
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 Code60505-6067
Application NumberANDA209085
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEMETREXED DISODIUMActive
Quantity: 1000 mg in 40 mL
Code: 2PKU919BA9
Classification: ACTIM
MANNITOLInactive
Quantity: 1000 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT