FDA-filed SPL labeling · retrieved through openFDA

Chlorpromazine

Chlorpromazine is an older antipsychotic (a phenothiazine) used for schizophrenia and other psychotic disorders, mania, severe nausea and vomiting, hiccups, and several other conditions, in oral and injectable products.

Brand names PromaparThorazineChlorpromazine Hci
Drug class ⓘ Phenothiazines
Rx Forms 3 Routes Oral · Intramuscular
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 36 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 effectiveApr 24, 2024
Clinical labels in scope ⓘ36
AvailabilityRx
Earliest approval/marketing year ⓘ1974
FDA-listed product records ⓘ336
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026 🚨Recall on record · 24
⭐ Chlorpromazine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Chlorpromazine is an established medicine for schizophrenia, mania, severe nausea and vomiting, and several other conditions. It carries serious risks, including a boxed warning for older adults with dementia-related psychosis, tardive dyskinesia, and blood count changes. Take it exactly as prescribed and report warning signs promptly.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Older adults with dementia-related psychosis who take antipsychotic drugs have a higher risk of death. In trials, about 4.5% of treated patients died, compared with about 2.6% on placebo. Most deaths appeared to be heart-related (such as heart failure or sudden death) or infections (such as pneumonia).

Chlorpromazine Hydrochloride Injection is not approved to treat dementia-related psychosis. If you care for someone with dementia who takes this medicine, talk with their prescriber about the risks.

Read the full warning on DailyMed →

📖 Chlorpromazine: Patient Information Guide

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

What Chlorpromazine is used for

▾

Chlorpromazine is used for a broad set of conditions, depending on the product.

  • Psychotic disorders (oral concentrate and tablets)
  • Schizophrenia
  • Nausea and vomiting
  • Restlessness and apprehension before surgery
  • Acute intermittent porphyria
  • Add-on treatment for tetanus
  • Manic type of manic-depressive illness
  • Intractable hiccups
  • Severe behavioral problems in children 1 to 12 years old, and short-term treatment of hyperactive children with conduct disorders

How Chlorpromazine works

▾

The exact way chlorpromazine works is not known. It acts mainly on the brain, with calming and anti-nausea effects. It blocks adrenaline-type signals strongly and affects other chemical signals more weakly.

How Chlorpromazine is taken (dosage)

▾

Chlorpromazine comes as tablets and an oral concentrate taken by mouth, and as an injection given into a muscle. The dose is tailored to you and increased gradually until symptoms are controlled, then reduced to the lowest effective level.

  • Benefit for psychotic disorders may take weeks or months.
  • Older and debilitated patients usually need lower doses and slower increases.
  • Follow your prescriber and the label.

Chlorpromazine side effects in detail

▾

Many side effects are mild, especially early on.

  • Drowsiness
  • Dizziness on standing
  • Dry mouth
  • Stuffy nose
  • Constipation
  • Nausea
  • Weight gain and increased appetite
  • Sun sensitivity

Call your doctor promptly for signs of infection, jaundice, uncontrolled movements, high fever with stiff muscles, fainting or seizures.

Chlorpromazine warnings and precautions

▾
  • Dementia-related psychosis: older adults have a higher risk of death (boxed warning).
  • Tardive dyskinesia: involuntary movements that may be permanent.
  • Neuroleptic malignant syndrome: a rare, potentially fatal reaction.
  • Low white blood cells: watch for sore throat or infection, mostly in weeks 4 to 10.
  • Jaundice: mostly in weeks 2 to 4.
  • Falls and low blood pressure: they can lead to injuries.
  • Long-term use: skin pigmentation and eye changes can occur, so eye exams are suggested.

Chlorpromazine interactions: what it interacts with

▾

Be careful with these.

  • Alcohol: the effects add up and blood pressure may drop.
  • Barbiturates, narcotics and other CNS depressants: too much sedation.
  • Guanethidine and similar drugs: chlorpromazine may counteract their blood pressure effect.
  • Lithium: a serious brain syndrome has been reported, so you need close monitoring.

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

Before taking Chlorpromazine

▾
  • Do not use it if you are allergic to phenothiazines.
  • Do not use it in a coma-like state or with large amounts of CNS depressants.
  • Tell your doctor about bone marrow problems or past blood or jaundice reactions.
  • Use it cautiously with liver disease.
  • Older adults need closer monitoring.
  • Pregnancy: use only if essential. Newborns may have withdrawal or movement symptoms.
  • Breastfeeding: it passes into breast milk.
  • Injection: it contains sulfites, which can trigger allergic reactions.

Chlorpromazine overdose: if you take too much

▾

Too much chlorpromazine can cause extreme drowsiness or coma, low blood pressure, muscle movement problems, agitation, seizures, fever and heart rhythm changes. Get emergency help right away. Treatment is supportive, including monitoring and keeping the airway open. Do not induce vomiting.

Pharmacodynamics: what Chlorpromazine does in the body

▾

Chlorpromazine acts mainly on the brain and nervous system, producing antipsychotic, sedative and anti-nausea effects. It has strong adrenaline-blocking activity, weaker anticholinergic activity, and slight antihistamine and anti-serotonin effects.

How to store Chlorpromazine

▾

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

📄 Written from Chlorpromazine’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 →

211

Supplements & herbs that interact with Chlorpromazine

211 supplements and herbal products have documented interactions with Chlorpromazine 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 · 17
  • Moderate · 159
  • Minor · 35
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major BEER Major CESIUM Major EPHEDRA Major GAMMA-HYDROXYBUTYRATE (GHB) Major +203 more
Every supplement checked against Chlorpromazine — ranked by severity The full interaction hub: 17 major · 159 moderate · 35 minor · every one linked to its full report. Check Chlorpromazine 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.

1

Nutrient depletion considerations

Chlorpromazine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

RIBOFLAVIN Insufficient Evidence
See the full Chlorpromazine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Chlorpromazine: pharmacist answers to common questions

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

What is chlorpromazine used for?

▾
It treats schizophrenia and other psychotic disorders, and the manic type of manic-depressive illness. It is also used for severe nausea and vomiting, stubborn hiccups, and a few other conditions. Your prescriber will tell you why it was chosen for you.

How should I take it?

▾
Take it exactly as prescribed. Your dose is usually raised gradually and later lowered to the lowest amount that works. Benefit for psychotic symptoms can take weeks or months, so don’t stop on your own.

What side effects should I expect?

▾
Drowsiness is common, especially in the first week or two. You may also have dizziness when standing, dry mouth, a stuffy nose, constipation or weight gain. Stand up slowly and be careful driving until you know how it affects you.

When should I call my doctor?

▾
Call right away for a sudden sore throat or fever, yellowing of the skin or eyes, or high fever with stiff muscles and confusion. Also call for uncontrolled movements of the face, tongue or jaw, or for fainting. These can be serious.

Can I drink alcohol with it?

▾
It’s best to avoid alcohol. Together they can add to drowsiness and lower your blood pressure. Also tell me about any other medicines you take, especially lithium or blood pressure drugs.

Is it safe in pregnancy or for older adults?

▾
It’s not recommended in pregnancy unless your doctor feels it’s essential, because newborns can have withdrawal or movement problems. Older adults with dementia-related psychosis have a higher risk of death with antipsychotics. Older adults generally need lower doses and close monitoring.

Is Chlorpromazine available over the counter?

▾
Chlorpromazine 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 Chlorpromazine first available?

▾
Chlorpromazine has been available in the United States since at least 1974, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Chlorpromazine?

▾
Chlorpromazine is supplied by 54 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Amneal Pharmaceuticals NY LLC, American Health Packaging.

💬 Answers drafted from Chlorpromazine’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 →

🧰 More about Chlorpromazine on HelloPharmacist

📊Chlorpromazine supplement interactions211 checked — ranked by severity 🌿Drug & Supplement CheckerChlorpromazine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Chlorpromazine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 Chlorpromazine forms and strengths (how it comes)

Chlorpromazine 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.

Tablet

By mouth
How this form is used
What it may be used for
  • Chlorpromazine tablets are used for psychotic disorders, schizophrenia, nausea and vomiting, and mania.
Important instructions
  • Chlorpromazine Hydrochloride tablets are taken by mouth, with the dose raised gradually and later lowered to the lowest effective level.
  • The higher-strength Chlorpromazine tablets (100 mg and 200 mg) are for severe neuropsychiatric conditions.
Available strengths 5 strengths
10 mg 25 mg 50 mg 100 mg 200 mg
279 FDA-listed product records ⓘ

Injection

Into a muscle
Brands Chlorpromazine Hci
How this form is used
What it may be used for
  • Chlorpromazine Hydrochloride injection is used for schizophrenia, nausea and vomiting, and mania.
  • Chlorpromazine Hci injection is also used for pre-surgery restlessness, intractable hiccups, tetanus (add-on) and acute intermittent porphyria.
Important instructions
  • Chlorpromazine Hydrochloride injection is given into a muscle, and the dose is raised only if low blood pressure has not occurred.
  • Chlorpromazine Hci injection can cause low blood pressure, so the patient should lie down and be watched for at least 30 minutes afterward.
Available strengths 1 strength
25 mg/mL
35 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Chlorpromazine hydrochloride oral concentrate is used for psychotic disorders, schizophrenia, nausea and vomiting, mania, and hiccups.
Important instructions
  • Chlorpromazine hydrochloride oral concentrate is taken by mouth, with the dose adjusted gradually to the individual.
Available strengths 2 strengths
30 mg/mL 100 mg/mL
12 FDA-listed product records ⓘ

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

How Chlorpromazine 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 ⓘ
54
Manufacturers
3
Brand names
336
FDA-listed product records ⓘ
1974
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 (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.11%
Amneal Pharmaceuticals NY LLC6%
American Health Packaging6%
Northstar Rx LLC5%
Golden State Medical Supply, Inc.5%
Zydus Pharmaceuticals (USA) Inc.5%
Other makers62%

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

📈 How widely Chlorpromazine is used (Medicaid data)

A general measure of how commonly Chlorpromazine 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 Chlorpromazine 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.

195,153
Medicaid prescriptions filled (Q1–Q4 2025)
$11.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Chlorpromazine prescribed? Of the 1,597 medications we measure, Chlorpromazine ranks #395 by Medicaid prescriptions — more than 75% of them.

Where Chlorpromazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #395 of 1,597
#390 Water 204,877 Rx #391 Metformin / Sitaglipti... 203,107 Rx #392 Silver Sulfadiazine 202,248 Rx #393 Levalbuterol Oral Inha... 197,722 Rx #394 Hydromorphone Injectio... 195,712 Rx #395 Chlorpromazine 195,153 Rx #396 Amlodipine and Benazep... 194,518 Rx #397 Ticagrelor 190,826 Rx #398 Atogepant 190,760 Rx #399 Phenytoin 189,728 Rx #400 Triamterene and Hydroc... 189,372 Rx

Utilization by Chlorpromazine 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 100 mg oral tablet is the most-dispensed Chlorpromazine product — about 32% of these Medicaid prescriptions.

chlorpromazine hydrochloride 100 MG Oral Tablet Most dispensed

62,393 Medicaid prescriptions (Q1–Q4 2025) 32% of Chlorpromazine prescriptions shown $4.1M gross reimbursement (before rebates) ≈ $65 per prescription (gross)

Summed across the 9 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991044

chlorpromazine hydrochloride 50 MG Oral Tablet

59,119 Medicaid prescriptions (Q1–Q4 2025) 30% of Chlorpromazine prescriptions shown $3M gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 10 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991336

chlorpromazine hydrochloride 25 MG Oral Tablet

38,705 Medicaid prescriptions (Q1–Q4 2025) 20% of Chlorpromazine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 11 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991194

chlorpromazine hydrochloride 200 MG Oral Tablet

27,719 Medicaid prescriptions (Q1–Q4 2025) 14% of Chlorpromazine prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $102 per prescription (gross)

Summed across the 11 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991188

chlorpromazine hydrochloride 10 MG Oral Tablet

5,499 Medicaid prescriptions (Q1–Q4 2025) 3% of Chlorpromazine prescriptions shown $146,747 gross reimbursement (before rebates) ≈ $27 per prescription (gross)

Summed across the 6 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991039

2 ML chlorpromazine hydrochloride 25 MG/ML Injection

947 Medicaid prescriptions (Q1–Q4 2025) <1% of Chlorpromazine prescriptions shown $93,502 gross reimbursement (before rebates) ≈ $99 per prescription (gross)

Summed across the 4 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1730078

1 ML chlorpromazine hydrochloride 25 MG/ML Injection

573 Medicaid prescriptions (Q1–Q4 2025) <1% of Chlorpromazine prescriptions shown $82,010 gross reimbursement (before rebates) ≈ $143 per prescription (gross)

Summed across the 6 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1730076

chlorpromazine hydrochloride 30 MG/ML Oral Solution

145 Medicaid prescriptions (Q1–Q4 2025) <1% of Chlorpromazine prescriptions shown $77,163 gross reimbursement (before rebates) ≈ $532 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991332

chlorpromazine hydrochloride 100 MG/ML Oral Solution

53 Medicaid prescriptions (Q1–Q4 2025) <1% of Chlorpromazine prescriptions shown $33,157 gross reimbursement (before rebates) ≈ $626 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 991053

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 Chlorpromazine, 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 59 of 311 listed Chlorpromazine NDCs with Medicaid activity.

🔍 Compare Chlorpromazine products

A representative set of FDA-listed product records for Chlorpromazine — 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 200 of 336 products — FDA National Drug Code Directory. See every product, package size and price: browse all 336 Chlorpromazine 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) Chlorpromazine RxCUI 2403 5 dose forms · 18 strengths
  2. Dose form (SCDF) Oral Solution RxCUI 371460 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 991238 hydrochloride 100 MG/ML RxCUI 991053 hydrochloride 2 MG/ML RxCUI 991184 hydrochloride 20 MG/ML RxCUI 991241 hydrochloride 30 MG/ML RxCUI 991332 hydrochloride 5 MG/ML RxCUI 991366
  3. Dose form (SCDF) Oral Suspension RxCUI 374968 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 20 MG/ML RxCUI 991344
  5. Dose form (SCDF) Rectal Suppository RxCUI 371464 No current FDA listing
    Clinical drug / strength (SCD) 25 MG RxCUI 992689 50 MG RxCUI 992701 100 MG RxCUI 199023 300 MG RxCUI 992699

Look up RxCUI 2403 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.

🏷️ Chlorpromazine brand names

Promapar Thorazine Chlorpromazine Hci

🏭 Who makes Chlorpromazine: manufacturers and labelers

Remedyrepack Inc. 35 Amneal Pharmaceuticals NY LLC 20 American Health Packaging 19 Northstar Rx LLC 17 Golden State Medical Supply, Inc. 15 Zydus Pharmaceuticals (USA) Inc. 15 Chartwell RX, LLC 15 AvPAK 15 Upsher-Smith Laboratories, LLC 15 Glenmark Pharmaceuticals Inc., USA 15 Zydus Lifesciences Limited 12 Major Pharmaceuticals 11 Lannett Company, Inc. 10 Zameer Pharmaceuticals LLC 10 Alembic Pharmaceuticals Inc. 10 Sun Pharmaceutical Industries Inc 10 Novadoz Pharmaceuticals LLC 6 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 5 Cadila Healthcare Limited 5 Upsher-Smith Laboratories, Inc. 5 Aurobindo Pharma Limited 5 Alembic Pharmaceuticals Limited 5 Sandoz, Inc. 4 Eugia US LLC 4

…and 16 more on the FDA NDC directory.

Chlorpromazine drug class (RxNorm)

Chlorpromazine belongs to the Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Phenothiazines with aliphatic side-chain

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 Chlorpromazine 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 Apr 24, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Chlorpromazine.
📈
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 Chlorpromazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
36
NDC products indexed
336
Distinct labelers/manufacturers represented
54
Linked representative label ⓘ
Alembic Pharmaceuticals Inc.
Linked label effective
Apr 24, 2024
Composite sections available
13
Linked SPL Set ID
4a0b3268-1d5a-4c98-af77-2461fb488476
Linked SPL Document ID
32f6b72b-6071-43f3-b50b-583e5b557d8e
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 36 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.