Quick answers
- What is Ephedrine sulfate used for?
- The FDA-approved label (Akovaz, Exela Pharma Sciences, LLC, November 27, 2020) says: “AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. AKOVAZ injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ephedrine sulfate have a boxed warning?
- No. None of the 34 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ephedrine sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ephedrine sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ephedrine sulfate?
- 24 companies list prescription products of Ephedrine sulfate in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Par Health USA, LLC and Fresenius Kabi USA, LLC.
What Ephedrine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. AKOVAZ injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
— FDA label: Akovaz, Exela Pharma Sciences, LLC, effective November 27, 2020. Read the full label on DailyMed →
The FDA has 34 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 34 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Emerphed Pfs, Akovaz, Emerphed |
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.
- Medical Purchasing Solutions, LLC6 products
- Par Health USA, LLC4 products
- Fresenius Kabi USA, LLC3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Gland Pharma Limited2 products
- Nexus Pharmaceuticals LLC2 products
- Exela Pharma Sciences, LLC2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Xiromed, LLC1 product
- Civica, Inc.1 product
- ProPharma Distribution1 product
- Nexus Pharamaceuticals Inc.1 product
- NorthStar Rx LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Somerset Therapeutics, LLC1 product
- Sandoz Inc1 product
- Baxter Healthcare Corporation1 product
- NorthStar RxLLC1 product
- Dr. Reddy's Laboratories Inc.1 product
- Caplin Steriles Limited1 product
- Remedyrepack Inc.1 product
- Lifestar Pharma LLC1 product
- Sagent Pharmaceuticals1 product
- Eugia US 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 |
|---|---|---|---|
| NDA208289 AKOVAZ | Exela Pharma | April 29, 2016 | 3, latest August 2, 2021 2021: Manufacturing (CMC) · 2020: Labeling · 2018: Labeling |
| NDA208943 CORPHEDRA | Ph Health | January 27, 2017 | — |
| NDA213407 EMERPHED | Nexus | April 17, 2020 | 2, latest August 15, 2024 2024: Labeling · 2023: Manufacturing (CMC) |
| NDA213994 EPHEDRINE SULFATE | Ph Health | October 16, 2020 | 1, latest April 22, 2022 2022: Manufacturing (CMC) |
Generic approvals (15)
- ANDA209784Sandoz · August 23, 2017
- ANDA212932Amneal · October 23, 2019
- ANDA209646Fresenius Kabi USA · August 4, 2020
- ANDA212649DR Reddys · October 3, 2020
- ANDA214334Hikma · December 15, 2020
- ANDA214579Eugia Pharma · June 14, 2021
- ANDA216146Gland · February 25, 2022
- ANDA216129Mankind Pharma · April 14, 2022
- ANDA215825Xiromed · April 21, 2022
- ANDA214528Sagent Pharms Inc · March 9, 2023
- ANDA219050Caplin · July 18, 2024
- ANDA217721Hikma · October 11, 2024
- ANDA218211Gland · January 16, 2025
- ANDA218271Fresenius Kabi USA · March 11, 2025
- ANDA216740Baxter Hlthcare Corp · July 8, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Akovaz, Exela Pharma Sciences, LLC, effective November 27, 2020; 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 →