Fluphenazine Hydrochloride 10 mg Tablet, Film Coated, 100-count
Other active recalls for Fluphenazine Hydrochloride (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Phenothiazine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Fluphenazine is an antipsychotic medication used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility. Fluphenazine is in a class of medications called antipsychotics. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Fluphenazine is an antipsychotic medication used to manage psychotic disorders — most commonly schizophrenia. It's available as tablets, an oral liquid, and injections. The long-ac...
- Fluphenazine Decanoate Injection is chemically designed to release slowly after a single shot, so one injection can keep working for up to four weeks or even longer. The regular ta...
- How is the long-acting injection different from the tablets or regular shot?
- The most common side effects involve movement — things like muscle stiffness, a restless, fidgety feeling, or tremors. These can often be managed by adjusting your dose or adding a...
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII U72Q2I8C85
A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 23ZQ42JZZH
A synthetic polymer made by chemically linking polyvinyl alcohol to polyethylene glycol. It acts as a binder and film-former to hold tablet ingredients together and create smooth coatings on capsules or tablets.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.380 | $37.98 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.9797 | $97.97 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.5833 | $58.33 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluphenazine Hydrochloride 10 mg 00527-1791-01 | Lannett | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 00832-6006-11 | Upsher-Smith | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 00904-7160-61 | Major | 1 tablet | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochoride 10 mg 16571-0892-09 | Rising | 90 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 24979-0139-01 | Upsher-Smith | 100 tablets | $0.380 | — | Availability likely | — |
| Fluphenazine hydrochloride 10 mg 27241-0252-01 | Ajanta | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 31722-0387-01 | Camber | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 43598-0037-01 | Dr. | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 50268-0369-15 | AvPAK | 1 tablet | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mgthis 51672-4236-01 | Sun | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 59651-0689-01 | Aurobindo | 100 tablets | $0.380 | — | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 60687-0761-01 | American | 1 tablet | $0.380 | AB | Availability likely | — |
| fluphenazine hydrochloride 10 mg 62135-0419-90 | Chartwell | 90 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 62332-0791-31 | Alembic | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 68462-0338-01 | Glenmark | 100 tablets | $0.380 | AB | Availability likely | — |
| fluphenazine hydrochloride 10 mg 69238-1681-01 | Amneal | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 70710-1491-01 | Zydus | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 70954-0276-10 | ANI | 100 tablets | $0.380 | AB | Availability likely | — |
| Fluphenazine Hydrochloride 10 mg 90096-0124-01 | Zameer | 100 tablets | $0.498 | AB | FDA listed | +31% |
| Fluphenazine Hydrochloride 10 mg 10135-0728-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 46708-0791-31 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 51407-0461-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 70518-4673-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 70771-1584-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 71205-0840-00 | Proficient | 100 tablets | — | — | FDA listed | — |
| Fluphenazine Hydrochloride 10 mg 72205-0115-05 | Novadoz | 500 tablets | — | AB | FDA listed | — |
| Fluphenazine Hydrochoride 10 mg 70518-4691-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51672-4236-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (51672-4236-1) | 2022-04-14 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING 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 ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluphenazine 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.
⏱️ Dosage and Administration ▾
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.
⛔ Contraindications ▾
CONTRAINDICATIONS Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
⚠️ Warnings ▾
WARNINGS 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. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (antipsychotic) drugs.
Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase.
However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process.
The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to neuroleptic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.
In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered.
However, some patients may require treatment despite the presence of the syndrome. (For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS, Information for Patients and ADVERSE REACTIONS, Tardive Dyskinesia .) Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and, 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no gen…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Central Nervous System The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants.
Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoate injection, and by subsequent reduction in dosage. Extrapyramidal Symptoms Dystonia Class Effect Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Tardive Dyskinesia See WARNINGS . The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely.
The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder.
This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome. Other CNS Effects Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy (see WARNINGS, Neuroleptic Malignant Syndrome ); leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS. Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts.
As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered. Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams. Autonomic Nervous System Hypertension and fluctuations in blood pressure have been reported with fluphenazine hydrochloride.
Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately.
Norepinephrine Bitartrate Injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure. Autonomic reactions including nausea and loss of a…
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Fluphenazine hydrochloride has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluphenazine Hydrochloride Tablets, USP are available as follows: 1 mg, film-coated, white, round tablets engraved "F" on one side and plain on the reverse side. Tablets free of spots or other defects. They are supplied in bottles of 100 (NDC 51672-4233-1).
2.5mg, film-coated, yellow, round tablets engraved "F3" on one side and plain on the reverse side. Tablets free of spots or other defects. They are supplied in bottles of 100 (NDC 51672-4234-1).
5 mg, film-coated, green, round tablets engraved "F2" on one side and plain on the reverse side. Tablets free of spots or other defects. They are supplied in bottles of 100 (NDC 51672-4235-1).
10 mg, film-coated, orange, round tablets engraved "F1" on one side and plain on the reverse side. Tablets free of spots or other defects. They are supplied in bottles of 100 (NDC 51672-4236-1) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
📋 Description ▾
DESCRIPTION Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below: C 22 H 26 F 3 N 3 OS∙2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet.
Each tablet also contains D&C yellow no. 10 aluminum lake (2.5 mg tablet), ferric oxide red (10 mg tablet), ferric oxide yellow (5 mg tablet and 10 mg tablet), FD&C blue no.1 aluminum lake (5 mg tablet), FD&C blue no. 2 aluminum lake (2.5 mg tablet), FD&C yellow no.
6 aluminum lake (2.5 mg tablet and 10 mg tablet), glyceryl mono and di-caprylocaprate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol graft polyethylene glycol copolymer, pregelatinized starch, purified water, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide. Chemical Structure
💬 Information for Patients ▾
Information for Patients Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.