Prescription medicine
Propofol Brand names: Diprivan
Propofol (Diprivan) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.171 per mL (Propofol 200 mg/20 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the propofol FDA label on DailyMed (effective September 11, 2025, Fresenius Kabi USA, LLC); the NDA 19627 record on Drugs@FDA; every propofol label on DailyMed.
Highlights of the record
FDA label of September 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDIPRIVAN is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
I
Forms and strengths
- 10 mg/ml
Injection (emulsion).
On the market
- Earliest approval on file
- October 2, 1989 Diprivan, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first January 4, 1999; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 13 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.171 per mL Propofol 200 mg/20 mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 18 since 2012 4 Class I among all firms' recalls; latest August 22, 2022; 1 more by firms not listed as its makers
- FAERS reports
- 36,431 through July 30, 2026
What is propofol used for?
From the label: indications and usageDIPRIVAN is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4 )]. […]
FDA pharmacologic class: General Anesthetic.
Source: FDA drug label (Diprivan), Fresenius Kabi USA, LLC, effective September 11, 2025 (SPL set e3105799-a4b6-f3f4-e6e2-b2b29bbdb538), via openFDA; the full label on DailyMed
Is there a generic for propofol (Diprivan)?
The FDA approved the first generic propofol on January 4, 1999. 12 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists propofol from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 1999 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 propofol (Diprivan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.171 per mL (Propofol 200 mg/20 mL vial), up 24% from $0.138 on October 8, 2025. 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.
- Propofol 200 mg/20 mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Propofol 200 mg/20 mL vial | Generic | $0.171 per mL | $3.42 per vial | +24% |
| Propofol 500 mg/50 mL vial | Generic | $0.171 per mL | $8.55 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
Has propofol been recalled?
The FDA's Enforcement Report lists 19 recalls naming propofol since 2012: 4 Class I (the most serious), 15 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of propofol and that holds 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 |
|---|---|---|---|
| August 22, 2022 | Class I | Pfizer Inc. | Presence of particulate matter |
| July 13, 2022 | Class I | Pfizer Inc. | Presence of particulate matter: particulate identified as a beetle. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
| December 23, 2014 | Class II | Hospira Inc. | Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. |
| October 6, 2014 | Class I | Hospira Inc. | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. |
| April 2, 2014 | Class I | Hospira Inc. | Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained … |
| December 12, 2013 | Class II | Hospira Inc. | Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate … |
| October 11, 2013 | Class II | Hospira Inc. | Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the propofol label say about other medicines?
The propofol label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name propofol. 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 |
|---|---|---|
| Atropine | warnings and precautions | The intravenous administration of anticholinergic agents (e.g., atropine or glycopyrrolate) should be considered to modify potential increases in vagal tone due to concomitant agents (e.g., succinylcholine) or surgical stimuli. |
| Desflurane | drug interactions | The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with DIPRIVAN are routinely used. |
| Droperidol | drug interactions | … fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). |
| Edetate | warnings and precautions | DIPRIVAN is a single-dose parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. |
| Fentanyl | drug interactions | DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates … |
| Glycopyrrolate | warnings and precautions | The intravenous administration of anticholinergic agents (e.g., atropine or glycopyrrolate) should be considered to modify potential increases in vagal tone due to concomitant agents (e.g., succinylcholine) or surgical stimuli. |
| Isoflurane | drug interactions | The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with DIPRIVAN are routinely used. |
| Lidocaine | warnings and precautions | Pain during intravenous injection may also be reduced by prior injection of intravenous lidocaine (1 mL of a 1% solution). |
| Meperidine | drug interactions | DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates … |
| Morphine | drug interactions | DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates … |
| Nitrous oxide | drug interactions | Analgesic Agents During maintenance of anesthesia or sedation, the rate of DIPRIVAN administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids). |
| Sevoflurane | drug interactions | The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with DIPRIVAN are routinely used. |
| Succinylcholine | drug interactions | Common Neuromuscular Blocking Agents DIPRIVAN does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants). |
Other labels that name propofol
Source: FDA drug label (Diprivan), Fresenius Kabi USA, LLC, effective September 11, 2025 (SPL set e3105799-a4b6-f3f4-e6e2-b2b29bbdb538), via openFDA; the full label on DailyMed
What do FAERS reports show for propofol?
The FDA Adverse Event Reporting System holds 36,431 reports that list propofol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,941 are coded as a death and 15,592 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 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
- Propofol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other