Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211363

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NDA 211363 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Baxter Hlthcare Corp, Bpi Labs, Deva Hlding, Fresenius Kabi Usa, Gland, Hikma, Intl Medication Sys, Hospira, and Teva Pharms Usa, and is included in eighteen NDAs. It is available from eighteen suppliers. There is one patent protecting this drug. Additional details are available on the EPINEPHRINE profile page.

The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.

Summary for 211363

Tradename:	EPINEPHRINE
Applicant:	Intl Medication Sys
Ingredient:	epinephrine
Patents:	0

Pharmacology for NDA: 211363

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for 211363

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Bronchodilator Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 211363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS	211363	NDA	Henry Schein, Inc.	0404-9806	0404-9806-10	1 SYRINGE in 1 BAG (0404-9806-10) / 10 mL in 1 SYRINGE
EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS	211363	NDA	A-S Medication Solutions	50090-7037	50090-7037-0	1 CARTON in 1 PACKAGE (50090-7037-0) / 1 mL in 1 CARTON

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Aug 15, 2022	TE:		RLD:	Yes

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