Prescription medicine
Norepinephrine Brand names: Levophed
Norepinephrine (Levophed) is a prescription medicine with an FDA approval on record since 1950. FDA's NDC Directory lists it from 20 generic labelers.
- Generic listed
Check it at the source: the norepinephrine FDA label on DailyMed (effective June 12, 2025, Hospira, Inc.); the NDA 7513 record on Drugs@FDA; every norepinephrine label on DailyMed.
Highlights of the record
FDA label of June 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Forms and strengths
- 0.016 mg/ml
- 0.032 mg/ml
- 0.064 mg/ml
- 0.128 mg/ml
- 1 mg/ml
- 4 mg/250ml
- 8 mg/250ml
- 16 mg/250ml
Injection (solution); injection (solution) (concentrate); injection; solution.
On the market
- Earliest approval on file
- July 13, 1950 Levophed, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first March 3, 2003; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 20 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- March 8, 2041 Norepinephrine Bitartrate In 5% Dextrose injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 47 since 2013 1 Class I among all firms' recalls; latest March 20, 2026; 7 more by firms not listed as its makers
- FAERS reports
- 14,307 through July 30, 2026
What is norepinephrine used for?
From the label: indications and usageLEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension. LEVOPHED is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.
FDA pharmacologic class: Catecholamine.
Source: FDA drug label (LEVOPHED), Hospira, Inc., effective June 12, 2025 (SPL set 2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10), via openFDA; the full label on DailyMed
Is there a generic for norepinephrine (Levophed)?
The FDA approved the first generic norepinephrine on March 3, 2003. 22 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists norepinephrine from 20 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Levophed injection; a patent listed only for Norepinephrine Bitartrate In 5% Dextrose injection runs to March 8, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1950 earliest approval on file
- 2003 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has norepinephrine been recalled?
The FDA's Enforcement Report lists 54 recalls naming norepinephrine since 2013: 1 Class I (the most serious), 45 Class II, 8 Class III; 5 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of norepinephrine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 20, 2026 | Class II | Fagron Compounding Services | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| January 23, 2024 | Class II | Baxter Healthcare Corporation | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; … |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| July 7, 2023 | Class II | SterRx, LLC | Lack of Assurance of Sterility |
| May 2, 2023 | Class II | Apollo Care, LLC | Lack of Assurance of Sterility |
| April 28, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. |
| March 29, 2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine … |
| April 25, 2022 | Class II | SCA Pharmaceuticals | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the norepinephrine label say about other medicines?
The norepinephrine label names 11 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | Tricyclic Antidepressants Co-administration of LEVOPHED with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. |
| Clomipramine | drug interactions | Tricyclic Antidepressants Co-administration of LEVOPHED with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. |
| Desflurane | drug interactions | Concomitant use of LEVOPHED with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. |
| Desipramine | drug interactions | Tricyclic Antidepressants Co-administration of LEVOPHED with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. |
| Imipramine | drug interactions | Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. |
| Isoflurane | drug interactions | Concomitant use of LEVOPHED with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. |
| Linezolid | drug interactions | MAO-Inhibiting Drugs Co-administration of LEVOPHED with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension. |
| Nortriptyline | drug interactions | Tricyclic Antidepressants Co-administration of LEVOPHED with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. |
| Phentolamine | warnings and precautions | Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. |
| Protriptyline | drug interactions | Tricyclic Antidepressants Co-administration of LEVOPHED with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. |
| Sevoflurane | drug interactions | Concomitant use of LEVOPHED with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. |
Other labels that name norepinephrine
Source: FDA drug label (LEVOPHED), Hospira, Inc., effective June 12, 2025 (SPL set 2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10), via openFDA; the full label on DailyMed
What do FAERS reports show for norepinephrine?
The FDA Adverse Event Reporting System holds 14,307 reports that list norepinephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,858 are coded as a death and 7,609 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other catecholamines
- the pharmacologic class, with prices and generics
- Norepinephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other