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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 219443

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NDA 219443 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent, and is included in twenty-one NDAs. It is available from twenty suppliers. There are thirteen 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-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 219443

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Biocon Pharma
Ingredient:	norepinephrine bitartrate
Patents:	0

Pharmacology for NDA: 219443

Medical Subject Heading (MeSH) Categories for 219443

Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 219443

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	219443	ANDA	BIOCON PHARMA INC.	70377-121	70377-121-12	10 VIAL, SINGLE-DOSE in 1 CARTON (70377-121-12) / 4 mL in 1 VIAL, SINGLE-DOSE (70377-121-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Mar 21, 2025	TE:	AP	RLD:	No

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