Drugplain

norepinephrine bitartrate 1 mg/mL

norepinephrine bitartrate · INJECTION, SOLUTION · Avenacy, LLC

10 Recalls on Record
Plain English

norepinephrine bitartrate is a injection, solution containing norepinephrine bitartrate at 1 mg/mL, taken intravenous. Manufactured by Avenacy, LLC.

Key Facts

Brand Name
norepinephrine bitartrate
Generic Name
norepinephrine bitartrate
NDC Code (Product)
83634-307
Manufacturer
Avenacy, LLC
Strength
1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA219924
Marketing Start
02/01/2026

Recall History

10 Recalls on Record
Class II04/20/2016

Pharmakon Pharmaceuticals, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/18/2017

Hospira Inc., A Pfizer Company

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

TerminatedVoluntary: Firm initiated
Class II09/25/2024

Fresenius Kabi Compounding, LLC

cGMP violations

TerminatedVoluntary: Firm initiated
Class II03/14/2022

Athenex Pharma Solutions, LLC

Defective container

TerminatedVoluntary: Firm initiated
Class II07/29/2021

Teva Pharmaceuticals USA

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II03/14/2022

Athenex Pharma Solutions, LLC

Defective container

TerminatedVoluntary: Firm initiated
Class II02/22/2023

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/12/2018

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

TerminatedVoluntary: Firm initiated
Class II06/12/2018

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

TerminatedVoluntary: Firm initiated
Class II06/14/2018

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective388 reports
condition aggravated282 reports
hypotension265 reports
off label use250 reports
sepsis234 reports
multiple organ dysfunction syndrome229 reports
cardiogenic shock204 reports
stress199 reports
general physical health deterioration180 reports
renal failure172 reports

Frequently Asked Questions

What is norepinephrine bitartrate used for?

norepinephrine bitartrate contains norepinephrine bitartrate. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is norepinephrine bitartrate a controlled substance?

norepinephrine bitartrate is not classified as a controlled substance by the DEA.

What is the generic name for norepinephrine bitartrate?

The generic name for norepinephrine bitartrate is norepinephrine bitartrate. There are 12 other brand versions of norepinephrine bitartrate.

What is the NDC code for norepinephrine bitartrate 1 mg/mL?

The NDC (National Drug Code) for norepinephrine bitartrate 1 mg/mL is 83634-307, listed by Avenacy, LLC.