Quick answers
- What is Etomidate used for?
- The FDA-approved label (Amidate, Hospira, Inc., May 20, 2026) says: “AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Etomidate have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Etomidate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Etomidate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Etomidate?
- 12 companies list prescription products of Etomidate in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Hikma Pharmaceuticals USA Inc. and Fresenius Kabi USA, LLC.
What Etomidate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). …
— FDA label: Amidate, Hospira, Inc., effective May 20, 2026. Read the full label on DailyMed →
The FDA has 16 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 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Amidate |
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.
- HF Acquisition Co LLC, DBA HealthFirst5 products
- Hikma Pharmaceuticals USA Inc.4 products
- Fresenius Kabi USA, LLC3 products
- Armas Pharmaceuticals Inc.2 products
- Eugia US LLC2 products
- Mylan Institutional LLC2 products
- Caplin Steriles Limited2 products
- Fosun Pharma USA Inc.2 products
- Civica, Inc.2 products
- Gland Pharma Limited2 products
- Henry Schein, Inc.1 product
- Hospira, Inc.1 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 |
|---|---|---|---|
| NDA018227 AMIDATE | Hospira | September 7, 1982 | 15, latest April 27, 2017 2017: Labeling · 2002: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Generic approvals (5)
- ANDA202354Hikma · February 25, 2016
- ANDA201044Mylan Labs Ltd · February 7, 2017
- ANDA206126Eugia Pharma · February 24, 2017
- ANDA209058Gland · April 18, 2017
- ANDA215028Caplin · December 18, 2020
Shortage status
Current shortage · updated October 21, 2026 · first posted October 5, 2022
| Product | Amidate, Injection, 2 mg/mL (NDC 0409-6695-02) |
|---|---|
| Availability | Unavailable |
| Reason given | Other |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1654006, 1654008, 1654009, 1654011 |
|---|---|
| SPL set ID of the quoted label | b7ed5bf8-ba75-44dc-8f81-96b4ad5766be |
| FDA labels (SPL) | 16 |
| FDA applications | NDA018227, 5 ANDA |
| Active ingredients (FDA) | ETOMIDATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amidate, Hospira, Inc., effective May 20, 2026; 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 →