FDA-filed SPL labeling · retrieved through openFDA

Asenapine

Asenapine is an atypical antipsychotic used to treat schizophrenia and bipolar I disorder in adults, available as a sublingual tablet and as the Secuado transdermal patch.

Brand names SaphrisSecuado
Drug class ⓘ Atypical Antipsychotic
Rx Forms 3 Routes Sublingual · Transdermal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 6 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 →

At a glance
Linked label effectiveFeb 25, 2025
Clinical labels in scope ⓘ6
AvailabilityRx
Earliest approval/marketing year ⓘ2009
FDA-listed product records ⓘ72
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026
Other forms & routes:
Transdermal
⭐ Asenapine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Asenapine is an atypical antipsychotic used to treat schizophrenia and bipolar I disorder, available as a sublingual tablet or — for schizophrenia in adults — the Secuado skin patch. It requires careful monitoring for metabolic changes, heart rhythm effects, and movement-related side effects. It must never be used in elderly patients with dementia-related psychosis due to a serious risk of death.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important safety warning: Asenapine should NOT be used to treat behavioral problems related to dementia in elderly patients. Older adults with dementia who are treated with antipsychotic medicines have a significantly higher risk of death compared to those taking a placebo. Most of these deaths were related to heart problems or infections like pneumonia. This risk applies to asenapine sublingual tablets, which are not approved for dementia-related psychosis. If you have a loved one with dementia, talk with their doctor about safer alternatives.

Read the full warning on DailyMed →

📖 Asenapine: Patient Information Guide

A plain-language walkthrough of Asenapine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Asenapine is an atypical antipsychotic available in sublingual tablet and transdermal patch forms, approved for the following conditions:

  • Schizophrenia in adults — sublingual tablets (Asenapine, Saphris) and the Secuado skin patch are both approved for this use
  • Bipolar I disorder — acute manic or mixed episodes in adults, as monotherapy (sublingual tablets only)
  • Bipolar I disorder — acute manic or mixed episodes in children and adolescents ages 10–17, as monotherapy (sublingual tablets only)
  • Bipolar I disorder — alongside lithium or valproate (adjunctive therapy) in adults (sublingual tablets only)
  • Bipolar I disorder — long-term maintenance treatment in adults (sublingual tablets only)
⚙️How it works▾

Asenapine works by blocking specific receptors in the brain, particularly dopamine D2 receptors and serotonin 5-HT2A receptors. These receptor systems are thought to play a role in symptoms of schizophrenia and mania, and by blocking them, asenapine helps reduce those symptoms. It also binds to a wide range of other serotonin, dopamine, adrenergic, and histamine receptors, which may contribute to both its therapeutic effects and some of its side effects.

The exact reason these receptor actions produce benefit in schizophrenia and bipolar I disorder is not fully understood, and the label notes the complete mechanism remains unknown.

💊How it's taken▾

The sublingual tablet forms (Asenapine, Saphris) are placed under the tongue twice daily and allowed to dissolve — do not eat or drink for 10 minutes afterward. The Secuado patch is applied to the skin once daily and worn for 24 hours before being replaced. Your prescriber will set the right dose and schedule for your condition; doses may be adjusted over time based on how you respond and tolerate the medication.

  • Sublingual tablets: taken twice daily; dissolve under tongue; no food or drink for 10 minutes after each dose
  • Secuado patch: applied once daily to a different skin site each time; worn continuously for 24 hours
🤒Side effects — in detail▾

The most commonly reported side effects with asenapine include:

  • Sleepiness (somnolence)
  • Numbness or tingling under the tongue (oral hypoesthesia)
  • Dizziness
  • Restlessness and urge to move (akathisia)
  • Muscle stiffness or movement problems (extrapyramidal symptoms)
  • Nausea and altered taste (dysgeusia)
  • Increased appetite and weight gain
  • Fatigue

Serious side effects that require immediate medical attention include signs of Neuroleptic Malignant Syndrome (high fever, severe muscle rigidity, confusion), uncontrolled repetitive movements that could signal tardive dyskinesia, dangerous drops in blood pressure, significant changes in blood sugar, irregular heartbeat, or severe allergic reactions including swollen tongue or trouble breathing.

⚠️Warnings & precautions▾
  • Elderly patients with dementia-related psychosis: Asenapine is not approved for this use and carries a significantly increased risk of death in this population — primarily from heart problems or infections. These patients also have a higher risk of stroke.
  • Neuroleptic Malignant Syndrome (NMS): A rare but potentially fatal reaction involving high fever, extreme muscle stiffness, confusion, and unstable heart rate or blood pressure. Stop the medication immediately and seek emergency care if these symptoms appear.
  • Tardive dyskinesia: Potentially irreversible, uncontrolled repetitive movements — risk increases with longer use and higher cumulative doses. Risk is highest in elderly women. Tell your doctor immediately if you notice unusual movements.
  • Metabolic changes: Asenapine can raise blood sugar (sometimes severely), worsen cholesterol levels, and cause weight gain. Regular monitoring is recommended.
  • QT prolongation: Asenapine can cause changes in heart rhythm. Avoid combining it with other drugs that have the same effect.
  • Orthostatic hypotension: Blood pressure can drop when standing, causing dizziness or fainting — especially in people with heart or blood vessel disease.
  • Low white blood cell count: Monitor for signs of infection, especially in patients with a history of low white blood cell counts.
🔀What it interacts with▾

Asenapine can interact with several medications, so always tell your doctor and pharmacist about everything you take:

  • Blood pressure medications (antihypertensives): Asenapine can lower blood pressure on its own, and combining it with blood pressure drugs can cause an exaggerated drop — monitor closely
  • Fluvoxamine (strong CYP1A2 inhibitor): Can raise asenapine levels in the blood; your dose may need to be reduced
  • Paroxetine: Asenapine can more than double paroxetine levels in the blood — the paroxetine dose typically needs to be cut in half
  • QT-prolonging drugs: Combining asenapine with other medications that affect heart rhythm increases the risk of a dangerous arrhythmia and should be avoided
  • Lithium and valproate: No clinically significant interaction with asenapine has been found; asenapine does not appear to affect their blood levels

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Severe liver disease (Child-Pugh C): Asenapine is contraindicated — drug levels can become dangerously high
  • Known allergy to asenapine or patch components (Secuado): Do not use; serious reactions including anaphylaxis, swollen tongue, and difficulty breathing have been reported
  • Elderly patients with dementia: Asenapine must not be used for dementia-related psychosis — risk of death is significantly elevated
  • Pregnancy: Babies exposed in the third trimester may have muscle stiffness, tremor, difficulty breathing, or withdrawal symptoms after birth; discuss risks with your doctor. A pregnancy exposure registry is available.
  • Breastfeeding: It is unknown whether asenapine passes into human breast milk; discuss the risks and benefits with your doctor
  • Children under 10: Safety and efficacy have not been evaluated
  • Children ages 10–17: Sublingual tablets are approved for bipolar I disorder monotherapy in this age group; dose escalation must be followed carefully to reduce the risk of muscle spasms (dystonia)
  • Older adults: May be more sensitive to blood pressure drops and other effects; monitor carefully, even though no specific dose adjustment is required based on age alone
  • Kidney disease: No dose adjustment is required for mild to severe kidney impairment
  • Seizure history: Use cautiously; asenapine may lower the seizure threshold
🚑If you take too much▾

In reported cases involving sublingual asenapine, the highest estimated overdose caused agitation and confusion. There is no specific antidote — treatment focuses on supportive care, including maintaining a clear airway, monitoring heart rhythm (ECG), and managing symptoms like low blood pressure or muscle stiffness. Call Poison Control at 1-800-222-1222 immediately if overdose is suspected.

📡Pharmacodynamics — effects in the body▾

Asenapine binds with high affinity to a broad range of receptors in the brain, including multiple serotonin (5-HT), dopamine (D1–D4), adrenergic, and histamine H1 receptors — acting as a blocker (antagonist) at all of them. It has little to no effect on muscarinic cholinergic receptors, which are responsible for many of the dry-mouth and constipation effects seen with some other antipsychotics. This broad receptor activity profile shapes both its therapeutic benefits and its side effect pattern.

🔬Pharmacokinetics — how your body processes it▾

When taken as a sublingual tablet, asenapine is absorbed quickly — peak blood levels are reached within about 30 to 90 minutes. Swallowing the tablet instead of letting it dissolve under the tongue greatly reduces absorption, which is why the tablet must not be swallowed. The drug has a half-life (time for the body to clear half of the drug) of about 24 hours, and steady levels in the blood are reached within about 3 days of twice-daily dosing. Asenapine is broken down mainly in the liver — primarily by an enzyme called CYP1A2 — so drugs that affect this enzyme can raise or lower asenapine levels in the blood.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

📄 Written from Asenapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

122

Supplements & herbs that interact with Asenapine

122 supplements and herbal products have documented interactions with Asenapine 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 · 9
  • Moderate · 78
  • Minor · 35
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major INDIAN SNAKEROOT Major RAUVOLFIA VOMITORIA Major +114 more
Every supplement checked against Asenapine — ranked by severity The full interaction hub: 9 major · 78 moderate · 35 minor · every one linked to its full report. Check Asenapine 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.

🩺 Pharmacist Counseling Corner

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

Why do I have to let the tablet dissolve under my tongue instead of just swallowing it? ▾
This is really important — swallowing the tablet dramatically reduces how much of the medication actually gets into your system. When it dissolves under your tongue, it absorbs directly into the bloodstream through the tissue there, which works much more effectively. Also, avoid eating or drinking for 10 minutes after it dissolves, for the same reason. Just think of it as a brief hold after each dose.
I feel really sleepy and dizzy since starting this — is that normal? ▾
Yes, sleepiness and dizziness are among the most commonly reported side effects, especially early on. The dizziness can be worse when you stand up quickly, because asenapine can cause your blood pressure to drop a bit when you change positions. Try standing up slowly and give your body a moment to adjust. If the drowsiness is severe or the dizziness is causing you to feel faint, let your doctor know — the dose or timing might be adjustable.
My tongue feels numb after I take the tablet — should I be worried? ▾
That mild numbness or tingling under the tongue is one of the most common side effects of the sublingual tablet form — it has a formal name, oral hypoesthesia. It typically fades on its own within a short time after the tablet dissolves. It's not a sign of a serious allergic reaction unless you also have swelling, difficulty swallowing or breathing, or a rash — in that case, get help right away. Otherwise, it's expected and generally not dangerous.
Are there any medications I should avoid while taking asenapine? ▾
Yes, a few interactions are worth knowing. If you take paroxetine (Paxil), asenapine can cause paroxetine levels to double in your blood — your doctor may need to reduce that dose. If you take fluvoxamine, it can raise asenapine levels, so your doctor may need to adjust your asenapine dose. Also, any medication that affects heart rhythm (QT-prolonging drugs) should be used with caution alongside asenapine. Always give your pharmacist and doctor a complete list of everything you take, including supplements.
Is it safe to use asenapine if I'm pregnant or trying to get pregnant? ▾
This is a conversation you really need to have with your doctor before stopping or continuing. Babies born to people who took antipsychotics in the third trimester can sometimes have temporary muscle stiffness, tremors, trouble feeding, or breathing difficulties after birth — though these usually resolve. There's also a pregnancy registry you can join to help researchers learn more: call 1-866-961-2388. Never stop the medication without talking to your doctor first, since untreated mental illness also carries real risks during pregnancy.
What warning signs should make me call my doctor or go to the ER right away? ▾
A few symptoms should never be ignored. If you develop a high fever along with severe muscle stiffness and confusion, go to the ER immediately — this combination can signal a rare but serious reaction called Neuroleptic Malignant Syndrome. Also call your doctor right away if you notice unusual, repetitive movements of your face, tongue, or limbs (this could be tardive dyskinesia), signs of high blood sugar like extreme thirst or frequent urination, or any swelling of the tongue, rash, or trouble breathing, which could indicate an allergic reaction.
Is Asenapine available over the counter? ▾
Asenapine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Asenapine first available? ▾
Asenapine has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Asenapine? ▾
Asenapine is supplied by 17 manufacturers listed in the FDA NDC Directory, including Allergan, Inc., Breckenridge Pharmaceutical, Inc., Noven Therapeutics, LLC.

💬 Answers drafted from Asenapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Asenapine supplement interactions122 checked — ranked by severity 🌿Drug & Supplement CheckerAsenapine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Asenapine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Asenapine comes

Asenapine 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.

Sublingual tablet

Under the tongue
Brands Saphris
How this form is used
What it may be used for
  • Saphris and Asenapine sublingual tablets are used to treat schizophrenia in adults
  • Saphris and Asenapine sublingual tablets are used for acute manic or mixed episodes of bipolar I disorder in adults and children ages 10–17
  • Saphris and Asenapine sublingual tablets are used alongside lithium or valproate (adjunctive therapy) for bipolar I disorder in adults
  • Saphris and Asenapine sublingual tablets are used for long-term (maintenance) treatment of bipolar I disorder in adults
Important instructions
  • Saphris and Asenapine sublingual tablets must be placed under the tongue and allowed to dissolve completely — do not swallow, crush, split, or chew
  • The tablet dissolves in saliva within seconds; do not eat or drink for 10 minutes after taking it
  • Saphris and Asenapine sublingual tablets are generally taken twice daily; follow your prescriber's specific instructions
  • Pediatric patients ages 10–17 using Saphris or Asenapine sublingual tablets for bipolar I disorder should have their dose increased gradually as directed — skipping the recommended schedule increases the risk of muscle spasms (dystonia)
Available strengths 4 strengths
2.5 mg 5 mg 10 mg 2.5 1
49 FDA-listed product records ⓘ

Skin patch

Through the skin
Brands Secuado
How this form is used
What it may be used for
  • Secuado is approved for the treatment of schizophrenia in adults only
Important instructions
  • Secuado is applied to clean, dry, intact skin on the upper arm, upper back, abdomen, or hip — apply one patch every 24 hours
  • Secuado should be worn continuously for 24 hours; rotate the application site with each new patch and never wear more than one patch at a time
  • Do not cut Secuado; if the edges lift, press them down firmly; if it falls off completely, apply a new patch to a different site
  • Do not apply heat sources (such as a heating pad) over a Secuado patch — heat increases the amount of medication absorbed into the blood
Available strengths 6 strengths
3.8 mg/d ASENAPINE 3.8 mg/d 5.7 mg/d ASENAPINE 5.7 mg/d 7.6 mg/d ASENAPINE 7.6 mg/d
9 FDA-listed product records ⓘ

Tablet

By mouth
Available strengths 3 strengths
2.5 mg 5 mg 10 mg
7 FDA-listed product records ⓘ

📊 Asenapine across the U.S. market

How Asenapine 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.

3
Dose forms ⓘ
17
Manufacturers
4
Brand names
72
FDA-listed product records ⓘ
2009
First marketed ⓘ

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 (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Allergan, Inc.17%
Breckenridge Pharmaceutical, Inc.14%
Noven Therapeutics, LLC13%
Alembic Pharmaceuticals Limited8%
Alembic Pharmaceuticals Inc.8%
Sigmapharm Laboratories, LLC8%
Other makers32%

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

📈 How widely Asenapine is used

A general measure of how commonly Asenapine 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 Asenapine 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.

47,447
Medicaid prescriptions filled (Q1–Q4 2025)
$17.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Asenapine prescribed? Of the 1,596 medications we measure, Asenapine ranks #644 by Medicaid prescriptions — more than 60% of them.

Where Asenapine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #644 of 1,596
#639 Eplerenone 48,763 Rx #640 Conjugated Estrogens /... 48,214 Rx #641 Sumatriptan Nasal 48,078 Rx #642 Darbepoetin Alfa Injec... 47,924 Rx #643 Sofosbuvir and Velpata... 47,731 Rx #644 Asenapine 47,447 Rx #645 Omeprazole / Sodium Bi... 47,423 Rx #646 Aprepitant 47,287 Rx #647 Capsaicin Topical 46,781 Rx #648 Bimatoprost 46,752 Rx #649 Trastuzumab Injection 46,422 Rx

Utilization by Asenapine 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 10 mg sublingual tablet is the most-dispensed Asenapine product — about 46% of these Medicaid prescriptions.

asenapine 10 MG Sublingual Tablet Most dispensed

21,860 Medicaid prescriptions (Q1–Q4 2025) 46% of Asenapine prescriptions shown $7.6M gross reimbursement (before rebates) ≈ $346 per prescription (gross)

Summed across the 5 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859975

asenapine 5 MG Sublingual Tablet

17,765 Medicaid prescriptions (Q1–Q4 2025) 37% of Asenapine prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $354 per prescription (gross)

Summed across the 5 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859981

asenapine 2.5 MG Sublingual Tablet

6,389 Medicaid prescriptions (Q1–Q4 2025) 13% of Asenapine prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $321 per prescription (gross)

Summed across the 3 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1606337

24 HR asenapine 0.238 MG/HR Transdermal System

588 Medicaid prescriptions (Q1–Q4 2025) 1% of Asenapine prescriptions shown $854,858 gross reimbursement (before rebates) ≈ $1,454 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261750

24 HR asenapine 0.158 MG/HR Transdermal System

471 Medicaid prescriptions (Q1–Q4 2025) <1% of Asenapine prescriptions shown $651,605 gross reimbursement (before rebates) ≈ $1,383 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261741

24 HR asenapine 0.317 MG/HR Transdermal System

374 Medicaid prescriptions (Q1–Q4 2025) <1% of Asenapine prescriptions shown $545,282 gross reimbursement (before rebates) ≈ $1,458 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261758

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 Asenapine, 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 16 of 83 listed Asenapine NDCs with Medicaid activity.

🔍 Compare Asenapine products

A representative set of FDA-listed product records for Asenapine — 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 72 of 72 products — FDA National Drug Code Directory. See every product, package size and price: browse all 72 Asenapine NDCs →

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) Asenapine RxCUI 784649 2 dose forms · 6 strengths
  1. Dose form (SCDF) Sublingual Tablet RxCUI 859974 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 1606337 5 MG RxCUI 859981 10 MG RxCUI 859975

Look up RxCUI 784649 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.

🏷️ Sold under these brand names

Saphris Secuado

🏭 Manufacturers & labelers

Allergan, Inc. 12 Breckenridge Pharmaceutical, Inc. 10 Noven Therapeutics, LLC 9 Alembic Pharmaceuticals Limited 6 Alembic Pharmaceuticals Inc. 6 Sigmapharm Laboratories, LLC 6 Greenstone LLC 6 Msn Laboratories Private Limited 5 Catalent U.k. Swindon Zydis Limited 2 Catalent UK Swindon Zydis Limited 2 MSN Organics Private Limited 2 Sun Pharmaceutical Industries, Inc. 1 Olon SpA 1 Medichem S.A. 1 Dr. Reddy's Laboratories Limited 1 Centaur Pharmaceuticals Private Limited 1 Aspen Oss B.V. 1

RxNorm drug class

Asenapine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Diazepines, oxazepines, thiazepines and oxepines

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.

🔬 Where this comes from

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 Asenapine.
📈
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 Asenapine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
NDC products indexed
72
Distinct labelers/manufacturers represented
17
Linked representative label ⓘ
Alembic Pharmaceuticals Inc.
Linked label effective
Feb 25, 2025
Composite sections available
25
Linked SPL Set ID
16e1cc9f-7699-49ea-b179-acb65e162304
Linked SPL Document ID
d54a0a82-b197-46eb-9c1d-4e77960d6f60
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Alembic Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.