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Thiothixene

Thiothixene is an antipsychotic medication used to treat schizophrenia.

Brand name Navane
Drug class Typical Antipsychotic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 5 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 →

✓No current FDA shortage listed · checked Oct 6, 2026
Thiothixene at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Thiothixene (Navane) is an older first-generation antipsychotic for schizophrenia in adults and teens 12 and up; a thioxanthene, it works much like the piperazine phenothiazines, calming dopamine signaling in the brain, and has been around since about 1967, now available as a generic. Drowsiness, restlessness, dry mouth and constipation are the side effects people most often notice. Its boxed warning is a higher risk of death in elderly people with dementia-related psychosis, so it should not be used for them. Long term, watch for tardive dyskinesia (repetitive face or tongue movements that can be permanent), and get emergency help for high fever with severe stiffness, signs of neuroleptic malignant syndrome.

Clinical pearls

  • Rise slowly from sitting or lying, since it can drop blood pressure, especially alongside blood pressure medicines.
  • Carbamazepine can lower thiothixene levels, so the dose may need adjusting when carbamazepine starts or stops.
  • Neck spasms, trouble swallowing or a tongue that pushes out (dystonia) call for contacting your doctor right away.
  • Alcohol and sleep aids deepen its drowsiness, and stopping suddenly without your prescriber’s plan can bring symptoms back.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important safety warning: Thiothixene should NOT be used in elderly patients with dementia-related psychosis. Studies show that older adults with dementia who take antipsychotic medications — including thiothixene — have a significantly higher risk of death compared to those taking a placebo. Most of these deaths were due to heart-related causes (such as heart failure or sudden cardiac death) or infections like pneumonia. Thiothixene is not approved for this use. If you have a loved one with dementia, talk to their doctor about safer alternatives.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record1967
Companies listing it with the FDA4
FDA label last updatedFeb 25, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Thiothixene, written from its FDA label.

What Thiothixene is used for

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Thiothixene capsules are FDA-approved for one condition:

  • Schizophrenia — Thiothixene capsules are indicated for the management of schizophrenia in adults. Dosing is individualized based on symptom severity.
  • Thiothixene capsules are not recommended for children under 12 years of age, as safety has not been established in this group.
  • Thiothixene is not approved for treating behavioral complications in patients with dementia or intellectual disabilities.

How Thiothixene works

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Thiothixene belongs to the thioxanthene class of antipsychotics. It shares chemical and pharmacological properties with a subgroup of antipsychotics called piperazine phenothiazines, while differing from the aliphatic phenothiazine group. These properties allow it to act in the brain in ways that help reduce the symptoms of schizophrenia.

Thiothixene dosage

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Thiothixene capsules are taken by mouth. Your prescriber will start you at a low dose and increase it gradually based on how well your symptoms respond. Some people take it once a day; others divide their dose throughout the day.

  • Milder conditions: typically started at a lower dose taken multiple times daily
  • More severe conditions: a higher starting dose, taken twice daily, with adjustments over time
  • Do not exceed the total daily amount prescribed — going higher rarely increases benefit and raises the risk of side effects
  • If you miss a dose, follow your prescriber's instructions; never double up without guidance

Dosing details from the FDA-approved label

From the Thiothixene 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.

  • Schizophrenia, milder conditions
    • Initial dose of 2 mg three times daily
    • If indicated, a subsequent increase to 15 mg/day total daily dose is often effective
    • Dosage individually adjusted; small doses initially, gradually increased to optimal effective level based on patient response
  • Schizophrenia, more severe conditions
    • Initial dose of 5 mg twice daily
    • Usual optimal dose is 20 mg to 30 mg daily
    • If indicated, an increase to 60 mg/day total daily dose is often effective
    • Maximum: Exceeding a total daily dose of 60 mg rarely increases the beneficial response
    • Dosage individually adjusted; small doses initially, gradually increased to optimal effective level based on patient response
  • Children under 12 years of age
    • Use is not recommended because safe conditions for its use have not been established
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of schizophrenia. In general, small doses should be used initially and gradually increased to the optimal effective level, based on patient response. Some patients have been successfully maintained on once-a-day thiothixene capsules therapy. The use of thiothixene capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established. In milder conditions, an initial dose of 2 mg three times daily is recommended. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective. In more severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 mg to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.

Read the full Dosage and Administration section on DailyMed →

Thiothixene side effects

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Thiothixene can cause a range of side effects. Common ones include:

Common side effects

  • Drowsiness or sedation
  • Restlessness or agitation
  • Dry mouth
  • Blurred vision
  • Constipation
  • Lightheadedness or low blood pressure
  • Fast heart rate (tachycardia)
  • Increased sweating
  • Restlessness, agitation, or trouble sleeping
  • Lightheadedness or low blood pressure, especially when standing up
  • Increased sweating or nasal congestion
  • Menstrual changes or breast changes in women
  • Nausea, loss of appetite, or weight changes

When to get medical help

  • Call your doctor right away if you develop uncontrolled or unusual muscle movements, especially of the face, tongue, or limbs — this may be tardive dyskinesia
  • Seek emergency help if you have a very high fever, severe muscle stiffness, confusion, or irregular heartbeat — these can be signs of neuroleptic malignant syndrome (NMS), a rare but life-threatening reaction
  • Tell your doctor if you have muscle spasms in the neck, trouble swallowing, difficulty breathing, or your tongue protrudes — these are signs of dystonia
  • Contact your doctor if you feel faint, have a sudden drop in blood pressure, or lose consciousness
  • Tell your doctor about any signs of infection such as fever or difficulty breathing
  • Tell your doctor if you notice yellowing of the skin or eyes, or unusual changes in mood or behavior

More serious reactions — including uncontrolled muscle movements (tardive dyskinesia), very high fever with muscle stiffness (neuroleptic malignant syndrome), or severe muscle spasms (dystonia) — require immediate medical attention. Contact your doctor or go to an emergency room if these occur.

Thiothixene warnings and precautions

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  • Increased mortality in elderly patients with dementia: Thiothixene is not approved for dementia-related psychosis. Elderly patients with dementia who take antipsychotics have a significantly higher risk of death — mostly from heart-related causes or infections. Do not use thiothixene for this purpose.
  • Tardive dyskinesia: Long-term use can cause involuntary, repetitive movements — often of the tongue, face, or mouth — that may be permanent. Risk increases with dose and duration. Report any unusual movements to your doctor promptly.
  • Neuroleptic malignant syndrome (NMS): A rare, potentially fatal reaction with symptoms including high fever, severe muscle rigidity, confusion, and unstable heart rate or blood pressure. Stop the medication and seek emergency care immediately if this occurs.
  • Dystonia: Muscle spasms — especially in the neck, throat, or tongue — can occur, particularly in the first few days of treatment and more often in younger males or at higher doses.
  • Drowsiness and driving: Thiothixene may impair your ability to drive or operate machinery, especially early in treatment.
  • Pregnancy: Newborns exposed in the third trimester may experience muscle problems or withdrawal symptoms after delivery. Use only if clearly necessary.

Thiothixene interactions

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Thiothixene can interact with several medications and substances. Key ones to know about:

  • Carbamazepine and other enzyme-inducing drugs: These speed up how quickly the body clears thiothixene, which can make it less effective. Your doctor may need to monitor and adjust your dose.
  • Blood pressure-lowering medications: Combining these with thiothixene can cause excessive drops in blood pressure. Close monitoring is needed.
  • Alcohol and CNS depressants (sedatives, sleep aids, anxiety medications): These add to thiothixene's sedating effects and can increase the risk of low blood pressure and drowsiness. Avoid or use with extreme caution.
  • Epinephrine: Should not be used to treat low blood pressure caused by thiothixene — it can paradoxically lower blood pressure further.

Interactions listed in the FDA-approved label

From the Thiothixene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Hepatic microsomal enzyme inducing agents, such as carbamazepine: Were found to significantly increase the clearance of thiothixene. Observe patients for signs of reduced thiothixene effectiveness.
  • Hypotensive agents: Possible additive effect with hypotensive agents. Observe patients closely for signs of excessive hypotension when thiothixene is added to their drug regimen.
Read the label’s full interactions text

DRUG INTERACTIONS Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. Patients receiving these drugs should be observed for signs of reduced thiothixene effectiveness 4,5 . Due to a possible additive effect with hypotensive agents, patients receiving these drugs should be observed closely for signs of excessive hypotension when thiothixene is added to their drug regimen 6 .

Read the full Drug Interactions section on DailyMed →

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 Thiothixene

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  • Do not take thiothixene if you are in a comatose state or have significant CNS (central nervous system) depression from any cause
  • Do not take thiothixene if you have circulatory collapse or a blood disorder (blood dyscrasia)
  • Do not take thiothixene if you have ever had a serious allergic reaction (hypersensitivity) to it
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding — this medication carries risks for the fetus, especially if taken in the third trimester
  • Thiothixene is not recommended for children under 12 years of age
  • Elderly patients with dementia should not take thiothixene — it is not approved for this use and increases the risk of death
  • Tell your doctor about all other medications you take, especially carbamazepine, blood pressure drugs, or any sedatives
  • Use caution driving or doing anything that requires full alertness until you know how thiothixene affects you

Thiothixene overdose

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Taking too much thiothixene can cause muscle twitching, drowsiness, and dizziness at lower excess amounts. A serious overdose can lead to severe CNS depression, muscle rigidity, tremor, difficulty swallowing, very low blood pressure, and coma. If an overdose is suspected, seek emergency medical help immediately — treatment focuses on supportive care, monitoring, and keeping the airway open.

How to store Thiothixene

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Store at 20° to 25°C (68° to 77°F). Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

51

Supplements & herbs that interact with Thiothixene

51 supplements and herbal products have documented interactions with Thiothixene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 37
  • Minor · 11
Every supplement checked against Thiothixene — ranked by severity The full interaction hub: 3 major · 37 moderate · 11 minor · every one linked to its full report. Check Thiothixene against your exact supplements

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.

Thiothixene: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Thiothixene — the kind of thing our pharmacy team would talk through with you at the counter.

What is thiothixene actually used for?

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Thiothixene is used to treat schizophrenia. It's an antipsychotic medication that helps manage the symptoms of this condition. Your prescriber will adjust your dose based on how severe your symptoms are and how your body responds to the medication.

How long does it take before I notice it working?

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The label doesn't specify an exact timeframe, but antipsychotic medications like thiothixene are generally started at a low dose and gradually increased. It's important to keep taking it as prescribed and check in regularly with your prescriber so they can fine-tune your dose based on how you're feeling.

What side effects should I watch out for?

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Some common ones include drowsiness, dry mouth, blurred vision, constipation, and lightheadedness — these often improve as your body adjusts. The ones to call your doctor about right away are uncontrolled muscle movements (especially in your face or tongue), very high fever with muscle stiffness, or muscle spasms in your neck or throat. These are uncommon but serious and need prompt attention.

Can I drink alcohol while taking this medication?

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It's best to avoid alcohol while taking thiothixene. Alcohol adds to the sedating effects of the medication and can also cause an excessive drop in blood pressure. Together, they can make you much more drowsy and increase your risk of falls or accidents.

Is it safe to take thiothixene during pregnancy?

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Thiothixene should only be used during pregnancy if your doctor decides the benefit clearly outweighs the risk. Babies born to mothers who took antipsychotics in the third trimester can sometimes have temporary muscle problems or withdrawal symptoms after delivery. Make sure your doctor knows if you are pregnant or planning to become pregnant.

Can an elderly family member with dementia take this medication?

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No — thiothixene is not approved for elderly patients with dementia-related psychosis, and it carries a serious risk. Studies have shown that older adults with dementia who take antipsychotic drugs like thiothixene have a significantly higher chance of dying compared to those who don't take them. Please talk to their doctor about safer options for managing dementia-related behavioral symptoms.

Is Thiothixene available over the counter?

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No. Thiothixene is a prescription medicine: every Thiothixene product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Thiothixene first available?

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The earliest FDA record we hold for Thiothixene is from 1967: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Thiothixene was first used.

Who makes Thiothixene?

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4 companies currently list Thiothixene products in the FDA's NDC Directory, including ANI Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Golden State Medical Supply, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Thiothixene on HelloPharmacist

Detailed data & references for Thiothixene Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Thiothixene forms and strengths (how it comes)

Thiothixene is available in 1 form. 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 Thiothixene inactive ingredients by manufacturer.

Capsule

By mouth
How this form is used
What it may be used for
  • Thiothixene capsules are used for the management of schizophrenia in adults
  • Thiothixene capsules are not recommended for children under 12 years of age
  • Thiothixene capsules are not approved for dementia-related psychosis
Important instructions
  • Thiothixene capsules are taken by mouth, with frequency (once daily or divided doses) determined by your prescriber based on symptom severity
  • Start at the lowest effective dose and increase gradually only as directed by your prescriber
  • Some patients on Thiothixene capsules are successfully maintained on a once-daily schedule
  • Do not exceed the total daily dose your prescriber has prescribed; going beyond the recommended maximum rarely adds benefit and increases risk
Available strengths 4 strengths
33 FDA-listed product records ⓘ

Thiothixene on the U.S. market: products, makers and brands

How Thiothixene 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.

4 companies list 13 Thiothixene product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1967. Brand names on the directory include Navane; the rest are generics.

1
Dose forms ⓘ
4
Labelers (makers, repackagers, distributors)
1
Brand names
13
FDA-listed product records ⓘ
1967
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

ANI Pharmaceuticals, Inc.31%
Amneal Pharmaceuticals NY LLC31%
Golden State Medical Supply, Inc.31%
Coupler LLC8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Thiothixene is used (Medicaid data)

A general measure of how commonly Thiothixene 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 Thiothixene 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.

3,413
Medicaid prescriptions filled (Q1–Q4 2025)
$331,873 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Thiothixene prescribed? Of the 1,601 medications we measure, Thiothixene ranks #1,106 by Medicaid prescriptions — more than 31% of them.

Where Thiothixene ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Thiothixene 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.

The 5 mg oral capsule is the most-dispensed Thiothixene product — about 48% of these Medicaid prescriptions.

thiothixene 5 MG Oral Capsule Most dispensed

1,640 Medicaid prescriptions (Q1–Q4 2025) 48% of Thiothixene prescriptions shown $152,127 gross reimbursement (before rebates) ≈ $93 per prescription (gross)

Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313366

thiothixene 10 MG Oral Capsule

1,051 Medicaid prescriptions (Q1–Q4 2025) 31% of Thiothixene prescriptions shown $135,664 gross reimbursement (before rebates) ≈ $129 per prescription (gross)

Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313361

thiothixene 2 MG Oral Capsule

673 Medicaid prescriptions (Q1–Q4 2025) 20% of Thiothixene prescriptions shown $42,683 gross reimbursement (before rebates) ≈ $63 per prescription (gross)

Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313364

thiothixene 1 MG Oral Capsule

49 Medicaid prescriptions (Q1–Q4 2025) 1% of Thiothixene prescriptions shown $1,399 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313362

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 Thiothixene, 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 8 of 42 listed Thiothixene NDCs with Medicaid activity.

Compare Thiothixene products

A representative set of FDA-listed product records for Thiothixene — 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.)

Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Thiothixene NDCs →

Thiothixene 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 no Thiothixene recalls since July 2021.

✅No Thiothixene recalls on record since July 2021

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.

Ingredient (IN) Thiothixene RxCUI 10510 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 374110 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 313362 2 MG RxCUI 313364 5 MG RxCUI 313366 10 MG RxCUI 313361
  2. Dose form (SCDF) Oral Solution RxCUI 374111 No current FDA listing
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 313368

Look up RxCUI 10510 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.

Thiothixene brand names

Thiothixene is sold under one brand name in the FDA directory — Navane. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Navane

Who makes Thiothixene: manufacturers and labelers

4 companies list Thiothixene products with the FDA. By number of product records, the largest are ANI Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Golden State Medical Supply, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

ANI Pharmaceuticals, Inc. 4 Amneal Pharmaceuticals NY LLC 4 Golden State Medical Supply, Inc. 4 Coupler LLC 1

Thiothixene drug class (RxNorm)

Thiothixene belongs to the Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Thioxanthene derivatives

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 Thiothixene 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 25, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Thiothixene.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Thiothixene after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
Finished products in the current FDA directory
13
Companies listing them (makers, repackagers, distributors)
4
FDA labeler codes behind them ⓘ
4
Linked representative label ⓘ
Novitium Pharma LLC
Linked label effective
Feb 25, 2025
Composite sections available
14
Linked SPL Set ID
b067b400-66cd-422d-a631-9ce0c935d2b2
Linked SPL Document ID
92792cc3-5d0e-4105-bf5a-03f2e479b8d7
Open the linked representative label on DailyMed ↗

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. Novitium Pharma LLC 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 →