Fluphenazine
Fluphenazine is an antipsychotic medication used to manage psychotic disorders, including schizophrenia, available in oral and injectable forms.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 34 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fluphenazine is a potent, older antipsychotic for schizophrenia and other psychotic disorders. It has been on the market since about 1959, is available generically, and is best known today for its long-acting shot given every few weeks. It is less sedating than many of its relatives, but movement effects like stiffness, inner restlessness and tremor are what people notice most. It carries a boxed warning for a higher risk of death in older adults with dementia-related psychosis, a use it is not approved for. Report any repetitive face or tongue movements (tardive dyskinesia, which can become permanent) right away, and treat high fever with rigid muscles and confusion (neuroleptic malignant syndrome) as an emergency.
Clinical pearls
- Make sure emergency staff know you take fluphenazine, because epinephrine (adrenaline) can backfire with it and drop blood pressure further.
- Expect periodic blood counts, and report a sore throat, mouth sores or unusual bruising, which can signal dangerous blood cell changes.
- Skip alcohol and be cautious with opioids, sleep aids and sedating antihistamines, since fluphenazine adds to their drowsiness.
- The long-acting shot releases slowly over weeks, so its side effects can linger and are worth reporting early.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important safety warning: Fluphenazine Decanoate Injection is not approved for elderly patients with dementia-related psychosis. Older adults with dementia who are treated with antipsychotic drugs — including fluphenazine — have a significantly higher risk of death compared to those taking a placebo. The deaths were most often related to heart problems (such as heart failure or sudden death) or infections like pneumonia. If you or a family member has dementia, talk to the prescriber about whether this medication is appropriate.
Patient information guide A plain-language walkthrough of Fluphenazine, written from its FDA label.
What Fluphenazine is used for
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Fluphenazine is an antipsychotic used to manage psychotic disorders across several formulations. The approved uses vary by product:
- Fluphenazine hydrochloride tablets and Fluphenazine Hydrochloride oral solution: management of psychotic disorders (oral route)
- Fluphenazine Hydrochloride Injection: management of psychotic disorders (intramuscular route)
- Fluphenazine Decanoate Injection: long-acting antipsychotic therapy for patients who need prolonged treatment — particularly chronic schizophrenia (intramuscular or subcutaneous route)
- None of the fluphenazine products have been shown effective for behavioral complications in patients with intellectual disability
- Fluphenazine Decanoate Injection is specifically not approved for dementia-related psychosis in elderly patients
How Fluphenazine works
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Fluphenazine works throughout the central nervous system, though its precise mechanism of action is not fully known. It belongs to the phenothiazine class of antipsychotics and is notably more potent milligram-for-milligram than many older drugs in its class. Compared to other phenothiazines, it tends to produce less sedation and is less likely to cause significant drops in blood pressure.
The decanoate form is chemically modified (esterified) so it releases slowly after injection, extending the drug's effect over weeks without reducing its therapeutic benefit. The hydrochloride form acts more quickly but requires more frequent dosing.
Fluphenazine dosage
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How fluphenazine is taken depends entirely on the formulation prescribed — do not assume they are interchangeable.
- Fluphenazine hydrochloride tablets and oral solution: Taken by mouth, typically in divided doses every 6 to 8 hours. Therapy starts at a low dose and is adjusted to the smallest amount that controls symptoms.
- Fluphenazine Hydrochloride Injection: Given intramuscularly, with doses divided every 6 to 8 hours. Once symptoms are controlled, the prescriber may transition to oral tablets.
- Fluphenazine Decanoate Injection: Given intramuscularly or subcutaneously; a single injection can be effective for up to 4 weeks or longer. The timing of repeat injections is based on individual response.
Always follow your prescriber's instructions exactly. Never stop fluphenazine suddenly without medical guidance.
Dosing details from the FDA-approved label
From the Fluphenazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Most patients (fluphenazine decanoate injection, initiation of therapy)
- 12.5 to 25 mg (0.5 to 1 mL) IM or SC may be given to initiate therapy
- Subsequent injections and dosage interval are determined in accordance with the patient's response
- Maximum: Dosage should not exceed 100 mg
- If doses greater than 50 mg are deemed necessary, the next and succeeding doses should be increased cautiously in increments of 12.5 mg
- Psychotic patients stabilized on a fixed daily dosage of oral fluphenazine hydrochloride (conversion to decanoate)
- 20 mg fluphenazine hydrochloride daily was equivalent to 25 mg (1 mL) of decanoate every three weeks
- Approximate conversion ratio of 12.5 mg (0.5 mL) of decanoate every three weeks for every 10 mg of fluphenazine hydrochloride daily
- Maximum: Dosage should not exceed 100 mg
- No precise formula can be given; adjust dosage at the time of each injection
- Severely agitated patients (decanoate injection)
- Treat initially with a rapid-acting phenothiazine such as fluphenazine hydrochloride injection
- When acute symptoms have subsided, 25 mg (1 mL) of fluphenazine decanoate may be administered
- Subsequent dosage is adjusted as necessary
- Maximum: Dosage should not exceed 100 mg
- "Poor risk" patients (known hypersensitivity to phenothiazines or disorders predisposing to undue reactions)
- Initiate cautiously with oral or parenteral fluphenazine hydrochloride
- When pharmacologic effects and appropriate dosage are apparent, an equivalent dose of fluphenazine decanoate may be administered
- Maximum: Dosage should not exceed 100 mg
- Patients with no history of taking phenothiazines
- May be advisable to treat initially with a shorter-acting form of fluphenazine before administering the decanoate
- Adult psychotic patients (oral fluphenazine hydrochloride, initial)
- Total daily dosage may range initially from 2.5 to 10 mg, divided and given at six- to eight-hour intervals
- May be increased if necessary until desired clinical effects are achieved
- Maximum: Daily doses up to 40 mg may be necessary; safety of prolonged administration of such doses not demonstrated in controlled studies
- Therapeutic effect is often achieved with doses under 20 mg daily
- Oral maintenance (when symptoms are controlled)
- Reduce gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose
- Geriatric patients (oral fluphenazine hydrochloride)
- Suggested starting dose is 1 to 2.5 mg daily, adjusted according to the response of the patient
- Age-related starting dose
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Depending on severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mg to 10 mg and should be divided and given at 6 to 8 hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately 2 to 3 times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage , which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 mg to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements. For psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the long-acting fluphenazine decanoate may be indicated (see package insert for fluphenazine decanoate for conversion information). For geriatric patients, the suggested starting dose is 1 mg to 2.5 mg daily, adjusted according to the response of the patient.
Read the full Dosage and Administration section on DailyMed →
Fluphenazine side effects
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Fluphenazine can cause a range of side effects — some common and manageable, others serious enough to require immediate attention.
Common side effects
- Movement problems such as muscle stiffness, restlessness, or tremor (extrapyramidal symptoms)
- Drowsiness or low energy
- Dry mouth
- Nausea or loss of appetite
- Headache
- Constipation
- Blurred vision
- Weight changes
- Movement-related effects: muscle stiffness, tremor, restlessness (akathisia), muscle spasms (dystonia), or Parkinson's-like symptoms — these are the most common side effects
- Headache, excessive sweating, increased saliva
- Blurred vision or nasal congestion
- Weight changes, menstrual irregularities, or sexual side effects
- Skin sensitivity to sunlight, rash, or itching
When to get medical help
- Call your doctor immediately if you develop uncontrolled, repetitive movements of the face, tongue, or limbs — this could be tardive dyskinesia
- Seek emergency care if you have high fever, severe muscle rigidity, confusion, or irregular heartbeat — these may be signs of neuroleptic malignant syndrome (NMS), a rare but life-threatening reaction
- Tell your doctor right away if you feel dizzy, faint, or fall, especially when standing up
- Contact your doctor if you notice unusual bruising, mouth sores, sore throat, or signs of infection — these could signal dangerous blood cell changes
- Seek help if you develop yellowing of the skin or eyes (jaundice), which may indicate liver problems
- Get immediate help for severe allergic reactions such as swelling, difficulty breathing, or widespread skin rash
Fluphenazine warnings and precautions
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Tardive dyskinesia (uncontrolled, often permanent involuntary movements of the face, tongue, and limbs) is one of the most serious risks — it is more likely with higher doses and longer treatment. There is no established cure, so your doctor will use the lowest effective dose for the shortest time possible and periodically reassess the need for continued treatment.
Neuroleptic malignant syndrome (NMS) — a potentially fatal reaction marked by high fever, severe muscle rigidity, altered mental state, and unstable pulse or blood pressure — has been reported with antipsychotics including fluphenazine. If this occurs, the drug must be stopped immediately and emergency treatment started. Additional important risks include: increased fall risk (due to dizziness and unsteadiness), dangerous drops in blood pressure in patients with heart or vascular conditions, serious blood cell abnormalities requiring routine monitoring, liver damage (especially early in treatment), and impaired ability to drive or operate machinery.
Fluphenazine interactions
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Fluphenazine can interact with several substances and medicines — tell your prescriber and pharmacist about everything you take.
- Alcohol: fluphenazine can significantly amplify alcohol's effects — avoid or strictly limit alcohol
- Opioid pain medicines, barbiturates, antihistamines, and other sedatives: combined use can increase drowsiness and other CNS depressant effects
- Large doses of hypnotics (sleep aids): should not be combined with fluphenazine
- Epinephrine (adrenaline): phenothiazines can reverse epinephrine's blood-pressure-raising effect, causing a dangerous further drop in blood pressure — emergency personnel must be told you take this drug
- Anesthetics: fluphenazine may intensify their effects; inform any surgical or anesthesia team
Interactions listed in the FDA-approved label
From the Fluphenazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Leukopenia, Neutropenia and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including fluphenazine hydrochloride. Agranulocytosis (including fatal cases) has also been reported.
Read the label’s full interactions text
Leukopenia, Neutropenia and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including fluphenazine hydrochloride. Agranulocytosis (including fatal cases) has also been reported. Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue fluphenazine hydrochloride at the first sign of a decline in WBC in the absence of other causative factors. Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm 3 ) should discontinue fluphenazine hydrochloride and have their WBC followed until recovery.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fluphenazine
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Certain people need to take extra care — or may not be able to take fluphenazine at all:
- Anyone with liver disease or blood disorders (blood dyscrasias) — these are contraindications
- Patients with suspected or established brain damage to the subcortical region of the brain
- Anyone in a comatose or severely depressed state — Fluphenazine Decanoate Injection is specifically contraindicated
- Elderly patients with dementia-related psychosis — significantly increased risk of death; Fluphenazine Decanoate Injection is not approved for this use
- Pregnant individuals — safety has not been established; weigh potential risks carefully with your doctor
- Children under 12 — Fluphenazine Decanoate Injection is not intended for this age group; safety and efficacy in children have not been established for any form
- People with heart, blood vessel, or kidney problems — higher risk of dangerous drops in blood pressure
- Anyone with a history of seizures — high doses should be avoided
- People with known allergy to fluphenazine or other phenothiazine medications — cross-sensitivity can occur
What Fluphenazine does in the body
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Fluphenazine acts at multiple levels of the central nervous system and affects multiple organ systems. It is more potent on a milligram basis than many other phenothiazines, produces less sedation, has less effect on potentiating CNS depressants and anesthetics than some phenothiazines, and is less likely to cause significant drops in blood pressure — though low blood pressure can still occur and appropriate precautions remain important.
How to store Fluphenazine
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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Avoid excessive heat. Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fluphenazine
148 supplements and herbal products have documented interactions with Fluphenazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 109
- Minor · 34
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Fluphenazine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fluphenazine — the kind of thing our pharmacy team would talk through with you at the counter.
What is fluphenazine actually used for?
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How is the long-acting injection different from the tablets or regular shot?
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What side effects should I know about going in?
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Can I drink alcohol while taking this medication?
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Is it safe to take fluphenazine during pregnancy?
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What should I watch for and when should I call my doctor?
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Is Fluphenazine available over the counter?
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When was Fluphenazine first available?
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Who makes Fluphenazine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluphenazine on HelloPharmacist
Fluphenazine forms and strengths (how it comes)
Fluphenazine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fluphenazine inactive ingredients by manufacturer.
Tablet
How this form is used
- Fluphenazine hydrochloride tablets are indicated for the management of psychotic disorders
- Fluphenazine hydrochloride tablets have not been shown effective for behavioral complications in patients with intellectual disability
- Fluphenazine hydrochloride tablets are taken by mouth, typically divided into doses every 6 to 8 hours as directed by your prescriber
- Treatment usually starts at a low dose and is adjusted gradually until symptoms are controlled
- When symptoms are well controlled, your doctor may consolidate to a single daily dose — follow their guidance
Injection
How this form is used
- Fluphenazine Decanoate Injection is a long-acting antipsychotic for patients with chronic schizophrenia who need extended treatment
- Fluphenazine Hydrochloride Injection is used for the management of psychotic disorders
- Fluphenazine Decanoate Injection is not approved for dementia-related psychosis or behavioral complications in patients with intellectual disability
- Fluphenazine Hydrochloride Injection has not been shown effective for behavioral complications in patients with intellectual disability
- Fluphenazine Decanoate Injection may be given intramuscularly or subcutaneously; a single injection may control symptoms for up to four weeks or longer
- Fluphenazine Decanoate Injection typically begins working within 24–72 hours of the shot, with meaningful effects on symptoms within 48–96 hours
- Fluphenazine Hydrochloride Injection is given intramuscularly, with doses typically divided and given every 6 to 8 hours as directed
- Fluphenazine Hydrochloride Injection: once symptoms are controlled, your doctor may transition you to oral maintenance therapy
Oral solution
How this form is used
- Fluphenazine Hydrochloride oral solution is indicated for the management of psychotic disorders
- Fluphenazine Hydrochloride oral solution has not been shown effective for behavioral complications in patients with intellectual disability
- Fluphenazine Hydrochloride oral solution is taken by mouth, typically divided into doses given every 6 to 8 hours
- The dose is carefully individualized — your prescriber will start low and adjust based on your response
- Follow your prescriber's and pharmacist's instructions exactly for measuring and taking the solution
Fluphenazine on the U.S. market: products, makers and brands
How Fluphenazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
35 companies list 116 Fluphenazine product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1959. Brand names on the directory include Permitil, Prolixin, Fluphenazine Decanoate and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fluphenazine is used (Medicaid data)
A general measure of how commonly Fluphenazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fluphenazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fluphenazine prescribed? Of the 1,601 medications we measure, Fluphenazine ranks #474 by Medicaid prescriptions — more than 70% of them.
Utilization by Fluphenazine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fluphenazine decanoate 25 MG/ML Injectable Solution Most dispensed
Summed across the 8 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859824
fluphenazine hydrochloride 5 MG Oral Tablet
Summed across the 13 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860918
fluphenazine hydrochloride 10 MG Oral Tablet
Summed across the 14 of 64 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859841
fluphenazine hydrochloride 2.5 MG Oral Tablet
Summed across the 12 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 865123
fluphenazine hydrochloride 1 MG Oral Tablet
Summed across the 10 of 58 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 865117
fluphenazine hydrochloride 2.5 MG/ML Injectable Solution
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 865129
fluphenazine hydrochloride 5 MG/ML Oral Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861848
fluphenazine hydrochloride 0.5 MG/ML Oral Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859835
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluphenazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 60 of 265 listed Fluphenazine NDCs with Medicaid activity.
Compare Fluphenazine products
A representative set of FDA-listed product records for Fluphenazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 25 mg/mL | Intramuscular, Subcutaneous | Bryant Ranch Prepack | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Endo USA, Inc. | ANDA | View NDC → |
| 125 mg/5 mL | Intramuscular, Subcutaneous | Eugia US LLC | ANDA | View NDC → |
| 2.5 mg/mL | Intramuscular | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Gland Pharma Limited | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Mylan Institutional LLC | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 25 mg/mL | Intramuscular, Subcutaneous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 💊Oral solution | ||||
| 0.5 mg/mL | Oral | PAI Holdings, LLC dba PAI Pharma | ANDA | View NDC → |
| 5 mg/mL | Oral | PAI Holdings, LLC dba PAI Pharma | ANDA | View NDC → |
| 💊Tablet | ||||
| 1 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 5 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 1 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 1 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 1 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 10 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 1 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 1 mg | Oral | AvPAK | ANDA | View NDC → |
| 2.5 mg | Oral | AvPAK | ANDA | View NDC → |
| 5 mg | Oral | AvPAK | ANDA | View NDC → |
| 10 mg | Oral | AvPAK | ANDA | View NDC → |
| 1 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 5 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 10 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 1 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 1 mg | Oral | Dr. Reddys Laboratories Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Dr. Reddys Laboratories Inc. | ANDA | View NDC → |
| 5 mg | Oral | Dr. Reddys Laboratories Inc. | ANDA | View NDC → |
| 10 mg | Oral | Dr. Reddys Laboratories Inc. | ANDA | View NDC → |
| 1 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 2.5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 10 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 1 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 2.5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 1 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Marlex Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 1 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 2.5 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 5 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 10 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 5 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 10 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 1 mg | Oral | Upsher-Smith Laboratories,LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Upsher-Smith Laboratories,LLC | ANDA | View NDC → |
| 5 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 5 mg | Oral | Upsher-Smith Laboratories,LLC | ANDA | View NDC → |
| 10 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 10 mg | Oral | Upsher-Smith Laboratories,LLC | ANDA | View NDC → |
| 1 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | Zameer Pharmaceuticals LLC | ANDA | View NDC → |
| 1 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 10 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 1 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 5 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 10 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
Showing 116 of 116 products — FDA National Drug Code Directory. See every product, package size and price: browse all 116 Fluphenazine NDCs →
Fluphenazine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluphenazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluphenazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluphenazine FDA approval history
How Fluphenazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fluphenazine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Fluphenazine recalls since July 2021, covering 3 product listings. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. Lots: Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027. FDA record D-0836-2026 →
- Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuti… Lots: Lot # 17232214, exp. date Sep-25 FDA record D-0327-2025 →
- Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuti… Lots: Lot # 17232206, exp. date Sep-25 FDA record D-0326-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4496 3 dose forms · 9 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 372237In current FDA listingsClinical drug / strength (SCD) decanoate 100 MG/MLRxCUI 865148decanoate 25 MG/MLRxCUI 859824hydrochloride 2.5 MG/MLRxCUI 865129 -
Dose form (SCDF) Oral Solution RxCUI 372239In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.5 MG/MLRxCUI 859835hydrochloride 5 MG/MLRxCUI 861848 -
Dose form (SCDF) Oral Tablet RxCUI 372240In current FDA listingsClinical drug / strength (SCD) hydrochloride 1 MGRxCUI 865117hydrochloride 10 MGRxCUI 859841hydrochloride 2.5 MGRxCUI 865123hydrochloride 5 MGRxCUI 860918
Look up RxCUI 4496 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fluphenazine supply and shortage status
Whether Fluphenazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fluphenazine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 10 mg | $0.431 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 5 mg | $0.148 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 1 mg | $0.213 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 2.5 mg | $0.224 per tablet | NDC details & price history |
| Injection, Solution · Intramuscular, Subcutaneous | 25 mg/mL | $10.84 per mL | NDC details & price history |
| Injection, Solution · Intramuscular, Subcutaneous | 125 mg/5 mL | $10.84 per mL | NDC details & price history |
| Injection, Solution · Intramuscular; Subcutaneous | 25 mg/mL | $10.84 per mL | NDC details & price history |
| Injection, Solution · Intramuscular; Subcutaneous | 125 mg/5 mL | $10.84 per mL | NDC details & price history |
| Tablet | 2.5 mg | $0.224 per tablet | NDC details & price history |
| Tablet | 5 mg | $0.148 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fluphenazine brand names
Fluphenazine is sold under 4 brand names in the FDA directory — Permitil, Prolixin, Fluphenazine Decanoate, Fluphenazine Hydrochoride. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluphenazine: manufacturers and labelers
35 companies list Fluphenazine products with the FDA. By number of product records, the largest are Upsher-Smith Laboratories, LLC, Novadoz Pharmaceuticals LLC, ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 11 more on the FDA NDC directory.
Fluphenazine drug class (RxNorm)
Fluphenazine belongs to the Phenothiazine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fluphenazine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →