Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218208

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NDA 218208 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 218208

Tradename:	EPINEPHRINE
Applicant:	Amneal
Ingredient:	epinephrine
Patents:	0

Pharmacology for NDA: 218208

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for 218208

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

Suppliers and Packaging for NDA: 218208

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	218208	ANDA	Amneal Pharmaceuticals Private Limited	80830-1659	80830-1659-2	25 VIAL, GLASS in 1 CARTON (80830-1659-2) / 1 mL in 1 VIAL, GLASS (80830-1659-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:	Dec 8, 2025	TE:	AP	RLD:	No

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