Last Updated: August 2, 2026

Details for New Drug Application (NDA): 040859

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NDA 040859 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, MSN, Mylan Labs Ltd, Nephron, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent, and is included in twenty-five NDAs. It is available from twenty-two suppliers. There are twelve patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE profile page.

The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 040859

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Baxter Hlthcare Corp
Ingredient:	norepinephrine bitartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 040859

Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Mar 27, 2012	TE:	AP	RLD:	No

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