Prescription medicine
Ketamine Brand names: Ketalar
Ketamine (Ketalar) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.556 per mL (Ketamine 500 mg/10 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- DEA Schedule III
Check it at the source: the ketamine FDA label on DailyMed (effective March 27, 2026, Par Health USA, LLC); the NDA 16812 record on Drugs@FDA; every ketamine label on DailyMed.
Highlights of the record
FDA label of March 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageKETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
Forms and strengths
- 10 mg/ml
- 50 mg/ml
- 100 mg/ml
Injection; injection (solution); injection (solution) (concentrate).
On the market
- Earliest approval on file
- February 19, 1970 Ketalar, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first March 22, 1996; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 10 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.556 per mL Ketamine 500 mg/10 mL vial
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest April 1, 2026; 24 more by firms not listed as its makers
- FAERS reports
- 4,846 through July 30, 2026
What is ketamine used for?
From the label: indications and usageKETALAR (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: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation ( 1 ) for the induction of anesthesia prior to the administration of other general anesthetic agents ( 1 ) as a supplement to other anesthetic agents ( 1 ).
FDA pharmacologic class: General Anesthetic.
Source: FDA drug label (Ketalar), Par Health USA, LLC, effective March 27, 2026 (SPL set 14e8f864-8b8a-4e7e-8439-e510d3107063), via openFDA; the full label on DailyMed
Is there a generic for ketamine (Ketalar)?
The FDA approved the first generic ketamine on March 22, 1996. 7 generic applications are approved; 6 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 ketamine from 10 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1996 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ketamine (Ketalar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.556 per mL (Ketamine 500 mg/10 mL vial). The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ketamine 500 mg/10 mL vial (generic)
- Ketalar 500 mg/10 mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ketamine 500 mg/10 mL vial | Generic | $0.556 per mL | $5.56 per vial | n/a |
| Ketamine 500 mg/5 mL vial | Generic | $1.78 per mL | $8.90 per vial | +14% |
| Ketalar 500 mg/10 mL vial | Brand | $0.672 per mL | $6.72 per vial | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is ketamine in shortage?
No ketamine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated November 7, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Ketamine Hydrochloride, Injection, 500 mg/5mL (100 mg/mL); Multiple Dose Glass Fliptop Vial Novaplus (NDC 0409-0040-10) | Pfizer Inc. | To Be Discontinued | November 7, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has ketamine been recalled?
The FDA's Enforcement Report lists 33 recalls naming ketamine since 2013: 0 Class I (the most serious), 31 Class II, 2 Class III; 8 still ongoing. 24 of them are by firms that FDA's NDC Directory does not list as a maker of ketamine 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 |
|---|---|---|---|
| April 1, 2026 | Class II | Wells Pharma of Houston LLC | cGMP deviations. |
| February 5, 2026 | Class II | Fresenius Kabi Compounding, LLC | Lack of Assurance of Sterility |
| October 9, 2025 | Class III | STAQ Pharma, Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date |
| June 2, 2025 | Class II | Tailstorm Health INC not a listed maker | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| March 31, 2025 | Class II | Denver Solutions, LLC DBA Leiters Health | Lack of Assurance of Sterility: Leaking/damaged syringes. |
| May 2, 2023 | Class II | Apollo Care, LLC | Lack of Assurance of Sterility |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ketamine label say about other medicines?
The ketamine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name ketamine. 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 |
|---|---|---|
| Aminophylline | drug interactions | DRUG INTERACTIONS Theophylline or Aminophylline: Do not co-administer with KETALAR as concomitant use may lower the seizure threshold ( 7.1 ). |
| Theophylline | drug interactions | DRUG INTERACTIONS Theophylline or Aminophylline: Do not co-administer with KETALAR as concomitant use may lower the seizure threshold ( 7.1 ). |
Other labels that name ketamine
Source: FDA drug label (Ketalar), Par Health USA, LLC, effective March 27, 2026 (SPL set 14e8f864-8b8a-4e7e-8439-e510d3107063), via openFDA; the full label on DailyMed
What do FAERS reports show for ketamine?
The FDA Adverse Event Reporting System holds 4,846 reports that list ketamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 539 are coded as a death and 1,529 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 rose sharply in 2025 (1,105, against a median of 143 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 general anesthetics
- the pharmacologic class, with prices and generics
- Ketamine side effects
- the label's list beside FAERS reports
- Ketamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other