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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218211

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NDA 218211 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mankind Pharma, Ph Health, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from nineteen suppliers. There are two patents protecting this drug. Additional details are available on the EPHEDRINE SULFATE profile page.

The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

Summary for 218211

Tradename:	EPHEDRINE SULFATE
Applicant:	Gland
Ingredient:	ephedrine sulfate
Patents:	0

Pharmacology for NDA: 218211

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Medical Subject Heading (MeSH) Categories for 218211

Adrenergic Agents
Central Nervous System Stimulants
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 218211

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	218211	ANDA	Gland Pharma Limited	68083-610	68083-610-10	10 VIAL in 1 CARTON (68083-610-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Jan 16, 2025	TE:	AP1	RLD:	No

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