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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 218144

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NDA 218144 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Hospira, Teva Pharms Usa, and Baxter Hlthcare Corp, and is included in fourteen NDAs. It is available from fifteen suppliers. Additional details are available on the EPINEPHRINE profile page.

The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are twenty-one 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 218144

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

Pharmacology for NDA: 218144

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for 218144

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

Suppliers and Packaging for NDA: 218144

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	218144	ANDA	Gland Pharma Limited	68083-591	68083-591-10	10 AMPULE in 1 BOX (68083-591-10) / 1 mL in 1 AMPULE
EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	218144	ANDA	GLENMARK PHARMACEUTICALS INC., USA	68462-933	68462-933-10	10 AMPULE in 1 BOX (68462-933-10) / 1 mL in 1 AMPULE (68462-933-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS			Strength	1MG/ML (1MG/ML)
Approval Date:	Jun 3, 2025	TE:	AP	RLD:	No

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