Last Updated: July 27, 2026

Details for New Drug Application (NDA): 216272

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NDA 216272 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 216272

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Nephron
Ingredient:	norepinephrine bitartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 216272

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:	Jun 11, 2026	TE:	AP	RLD:	No

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