Quick answers
- What is Ketamine hydrochloride used for?
- The FDA-approved label (Ketalar, Par Health USA, LLC, March 27, 2026) says: “KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents. KETALAR is a general anesthetic indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ketamine hydrochloride have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ketamine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ketamine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ketamine hydrochloride?
- 11 companies list prescription products of Ketamine hydrochloride in the FDA NDC Directory, including Eugia US LLC, Fresenius Kabi USA, LLC and Par Health USA, LLC.
What Ketamine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents. KETALAR is a general anesthetic indicated …
— FDA label: Ketalar, Par Health USA, LLC, effective March 27, 2026. Read the full label on DailyMed →
The FDA has 12 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 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution · Injection, solution, concentrate |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Ketalar |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ketamine hydrochloride 100 mg/mL injection | Generic | $1.81 per mL |
| ketamine hydrochloride 100 mg/mL injection, solution | Generic | $1.81 per mL |
| ketamine hydrochloride 100 mg/mL injection, solution, concentrate | Generic | $1.81 per mL |
| ketamine hydrochloride 50 mg/mL injection | Generic | $0.5563 per mL |
| ketamine hydrochloride 50 mg/mL injection | Brand: Ketalar | $0.6724 per mL |
| ketamine hydrochloride 50 mg/mL injection, solution | Generic | $0.5563 per mL |
| ketamine hydrochloride 50 mg/mL injection, solution, concentrate | Generic | $0.5563 per mL |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Eugia US LLC4 products
- Fresenius Kabi USA, LLC4 products
- Par Health USA, LLC3 products
- Gland Pharma Limited3 products
- Sagent Pharmaceuticals3 products
- Medical Purchasing Solutions, LLC2 products
- Civica, Inc.2 products
- Henry Schein, Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Hospira, Inc.2 products
- Baxter Healthcare Corporation1 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 |
|---|---|---|---|
| NDA016812 KETALAR | Ph Health | February 19, 1970 | 26, latest March 23, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
Generic approvals (6)
- ANDA074524Hikma · March 22, 1996
- ANDA074549Hospira · June 27, 1996
- ANDA076092Eugia Pharma · December 28, 2001
- ANDA215808Fresenius Kabi USA · January 13, 2023
- ANDA216809Gland · January 24, 2023
- ANDA219684Baxter Hlthcare Corp · September 17, 2025
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) — Ketalar, Par Health USA, LLC, effective March 27, 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 →