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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216582

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NDA 216582 describes PEMETREXED DISODIUM, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from twenty-one suppliers. Additional details are available on the PEMETREXED DISODIUM profile page.

The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for 216582

Tradename:	PEMETREXED DISODIUM
Applicant:	Prinston Inc
Ingredient:	pemetrexed disodium
Patents:	0

Pharmacology for NDA: 216582

Mechanism of Action	Folic Acid Metabolism Inhibitors

Medical Subject Heading (MeSH) Categories for 216582

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 216582

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	216582	ANDA	Solco Healthcare US, LLC	43547-632	43547-632-01	100 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (43547-632-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Dec 11, 2023	TE:	AP	RLD:	No

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