Last Updated: August 2, 2026

Details for New Drug Application (NDA): 218595

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NDA 218595 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 218595

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

Pharmacology for NDA: 218595

Medical Subject Heading (MeSH) Categories for 218595

Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 218595

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	218595	ANDA	Novadoz Pharmaceuticals LLC	72205-241	72205-241-07	10 VIAL in 1 CARTON (72205-241-07) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Dec 11, 2025	TE:	AP	RLD:	No

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