Pemetrexed
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . PEMETREXED for injection, for Intravenous Use Initial U.S. Approval: 2004
Approved
Approval ID
21a607a6-1ec3-e61b-7d89-c71e3bdc2e3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Biocon Pharma Inc
DUNS: 080000063
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 Code70377-022
Application NumberANDA211090
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pemetrexed disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (4)
MannitolInactive
Quantity: 1000 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Pemetrexed Disodium HemipentahydrateActive
Quantity: 1000 mg in 40 mL
Code: F4GSH45R4C
Classification: ACTIM