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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 215425

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NDA 215425 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 215425

Tradename:	EPINEPHRINE
Applicant:	Fresenius Kabi Usa
Ingredient:	epinephrine
Patents:	0

Pharmacology for NDA: 215425

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for 215425

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

Suppliers and Packaging for NDA: 215425

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	215425	NDA	Fresenius Kabi USA, LLC	63323-698	63323-698-30	1 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30) / 30 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	30MG/30ML (1MG/ML)
Approval Date:	Mar 13, 2025	TE:		RLD:	Yes

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