Quick answers
- What is Norepinephrine bitartrate used for?
- The FDA-approved label (Levophed, Hospira, Inc., June 12, 2025) says: “LEVOPHED 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norepinephrine bitartrate have a boxed warning?
- No. None of the 26 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Norepinephrine bitartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norepinephrine bitartrate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started January 23, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Norepinephrine bitartrate?
- 24 companies list prescription products of Norepinephrine bitartrate in the FDA NDC Directory, including Baxter Healthcare Corporation, WG Critical Care, LLC and Long Grove Pharmaceuticals, LLC.
What Norepinephrine bitartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LEVOPHED 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 label: Levophed, Hospira, Inc., effective June 12, 2025. Read the full label on DailyMed →
The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, solution, concentrate · Injection · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 37 in the FDA NDC Directory |
| Brand names | Levophed |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Baxter Healthcare Corporation6 products
- WG Critical Care, LLC4 products
- Long Grove Pharmaceuticals, LLC3 products
- Fresenius Kabi USA, LLC2 products
- Hospira, Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- BE Pharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Biocon Pharma Inc.1 product
- Caplin Steriles Limited1 product
- Gland Pharma Limited1 product
- Rising Pharma Holdings, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- Anthea Pharma Private Limited1 product
- Sandoz Inc1 product
- Sagent Pharmaceuticals1 product
- Avenacy, LLC1 product
- Civica, Inc.1 product
- Mylan Institutional LLC1 product
- Baxter Healthcare Company1 product
- Breckenridge Pharmaceutical, Inc.1 product
- NorthStar Rx LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Novadoz Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA007513 LEVOPHED | Hospira | July 13, 1950 | 12, latest October 21, 2020 2020: Labeling · 2020: Labeling · 2007: Manufacturing (CMC) |
| NDA214313 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | Baxter Hlthcare Corp | January 15, 2021 | 5, latest February 6, 2026 2026: Manufacturing (CMC) · 2024: Manufacturing (CMC) · 2023: Manufacturing (CMC) |
| NDA214628 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | Long Grove Pharms | October 6, 2022 | 1, latest December 3, 2024 2024: Manufacturing (CMC) |
| NDA215700 NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | Inforlife | September 15, 2022 | 3, latest October 15, 2025 2025: Manufacturing (CMC) · 2023: Labeling · 2023: Labeling |
Generic approvals (13)
- ANDA040455Meitheal · March 3, 2003
- ANDA211242Mylan Labs Ltd · October 4, 2018
- ANDA211359Sandoz · October 18, 2018
- ANDA203662Hikma · November 7, 2018
- ANDA211382Fresenius Kabi USA · November 3, 2020
- ANDA214455Breckenridge · January 22, 2021
- ANDA214323Gland · May 6, 2021
- ANDA217575Caplin · September 15, 2023
- ANDA218758Rising · May 13, 2024
- ANDA219163Aspiro · January 31, 2025
- ANDA219443Biocon Pharma · March 21, 2025
- ANDA219924Anthea Pharma · November 25, 2025
- ANDA218595Msn · December 11, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 23, 2024 · Class II · Ongoing · D-0336-2024
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20 — Baxter Healthcare Corporation
-
August 22, 2017 · Class II · Terminated · D-1168-2017
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04 — Pfizer Inc.
-
May 18, 2017 · Class II · Terminated · D-0898-2017
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04 — Hospira Inc., A Pfizer Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Levophed, Hospira, Inc., effective June 12, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →