Prescription medicine
Fluphenazine First approved as Permitil
Fluphenazine (Permitil) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.431 per fluphenazine 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fluphenazine FDA label on DailyMed (effective April 14, 2026, Amneal Pharmaceuticals NY LLC); the NDA 12034 record on Drugs@FDA; every fluphenazine label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
Used for
From the label: indications and usageFluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders.
Forms and strengths
- 1 mg
- 2.5 mg
- 5 mg
- 10 mg
- 0.5 mg/ml
- 2.5 mg/ml
- 5 mg/ml
- 25 mg/ml
- 125 mg/5ml
Film-coated tablet; tablet; injection (solution); injection; solution (concentrate).
On the market
- Earliest approval on file
- September 9, 1959 Permitil, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first November 7, 1985; 29 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 36 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.431 per tablet Fluphenazine 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 11 since 2013 0 Class I among all firms' recalls; latest August 25, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 537 through July 30, 2026
What is fluphenazine used for?
From the label: indications and usageFluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
FDA pharmacologic class: Phenothiazine.
Source: FDA drug label (fluphenazine hydrochloride), Amneal Pharmaceuticals NY LLC, effective April 14, 2026 (SPL set 5b443b30-5682-4cf3-9ed0-716efddbc865), via openFDA; the full label on DailyMed
Is there a generic for fluphenazine (Permitil)?
The FDA approved the first generic fluphenazine on November 7, 1985. 40 generic applications are approved; 29 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 fluphenazine from 36 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1959 earliest approval on file
- 1985 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 fluphenazine (Permitil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.431 per Fluphenazine 10 mg tablet, down 21% from $0.543 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Fluphenazine 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluphenazine 1 mg tablet | Generic | $0.213 per tablet | $6.38 | -40% |
| Fluphenazine 10 mg tablet | Generic | $0.431 per tablet | $12.93 | -21% |
| Fluphenazine 2.5 mg tablet | Generic | $0.224 per tablet | $6.71 | -47% |
| Fluphenazine 5 mg tablet | Generic | $0.148 per tablet | $4.45 | -64% |
| Fluphenazine dec 125 mg/5 mL | Generic | $10.84 per mL | n/a | -13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fluphenazine been recalled?
The FDA's Enforcement Report lists 12 recalls naming fluphenazine since 2013: 0 Class I (the most serious), 10 Class II, 2 Class III; 10 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fluphenazine 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 25, 2026 | Class III | Ajanta Pharma USA Inc | Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. … |
| August 13, 2026 | Class II | Safecor Health, LLC | Failed Stability Specifications |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| November 12, 2019 | Class II | AuroMedics Pharma LLC | Discoloration; Hazy solution found in one vial instead of a clear solution. |
| March 16, 2017 | Class III | Fresenius Kabi USA, LLC | Subpotent Drug |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluphenazine label say about other medicines?
The fluphenazine label names no other medicine on this site. The labels of 2 other medicines name fluphenazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name fluphenazine
Source: FDA drug label (fluphenazine hydrochloride), Amneal Pharmaceuticals NY LLC, effective April 14, 2026 (SPL set 5b443b30-5682-4cf3-9ed0-716efddbc865), via openFDA; the full label on DailyMed
What do FAERS reports show for fluphenazine?
The FDA Adverse Event Reporting System holds 537 reports that list fluphenazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 54 are coded as a death and 238 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?
- Alternatives to fluphenazine
- medicines labeled for the same conditions
- Other phenothiazines
- the pharmacologic class, with prices and generics
- Fluphenazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other