HomeNDC LookupIngredientsChlorpromazine › 46708-0738-31
Chlorpromazine 100 mg Tablet, 100-count — NDC 46708-0738-31 package photo

Chlorpromazine 100 mg Tablet, 100-count

by Alembic Pharmaceuticals Limited · 100 TABLET in 1 BOTTLE (46708-738-31)
NDC 46708-0738-31
🏷️ FDA NDC (as labeled) 46708-738-31 billing pads the product segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.5907/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 46708-738-31
Product NDC 46708-738
11-digit billing NDC 46708073831
UNII 9WP59609J6
UPC 0346708736316, 0346708737313, 0346708735319, 0346708738310
Application # ANDA217350
SPL Set ID 1f9751ff-33da-44be-9c1f-9bbf88ac543b
Established class (EPC) Phenothiazine
Chemical class Phenothiazines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-20
Route ORAL
Dosage form TABLET
Substance CHLORPROMAZINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 46708-738-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 46708-0738-31. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Phenothiazines with aliphatic side-chain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA217350 (ANDA)
Labeler code46708
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio502 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Chlorpromazine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) and other psychotic disorders (conditions that cause difficulty telling the difference between things or ideas that are real and things or ideas that are not real) and to treat the symptoms of mania (frenzied, abnormally excited mood) in people who have bipolar disorder (manic depressive disorder; a condition that causes episodes of mania, episodes of depression, and other abnormal moods). Chlorpromazine is al...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Chlorpromazine treats a range of conditions. Most commonly, it's prescribed for schizophrenia and other psychotic disorders, or to control the manic phase of manic-depressive illne...
  • What exactly is chlorpromazine used for?
  • It depends on what it's being used for. For psychotic disorders, full improvement can take weeks — or even months — so don't be discouraged if you don't feel a dramatic change righ...
  • Drowsiness is the most common early side effect, and it usually gets better after the first week or two. You might also notice dry mouth, nasal congestion, constipation, or lighthe...
📖 Read our full Chlorpromazine guide →
1
Nutrient depletion considerations

Chlorpromazine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White / Brown
ShapeRound
ImprintJ5
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 2S42T2808B
    A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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.
  • 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.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • 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.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.
  • 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.
  • 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.

17 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5907 $59.07 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorpromazine Hydrochloride 100 mg 00527-2964-37 Lannett 100 tablets $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 00832-6020-00 Upsher-Smith 100 tablets $0.592 AB Availability likely
Chlorpromazine hydrochloride 100 mg 16714-0050-01 Northstar 100 tablets $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 50268-0165-15 AvPAK 1 tablet $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 60687-0452-01 American 1 tablet $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 60687-0960-01 American 1 tablet $0.592 AB Availability likely
chlorpromazine hydrochloride 100 mg 62135-0423-90 Chartwell 90 tablets $0.592 AB Availability likely
ChlorproMAZINE Hydrochloride 100 mg 63304-0114-01 Sun 100 tablets $0.592 Discontinued
Chlorpromazine Hydrochloride 100 mg 68462-0864-01 Glenmark 100 tablets $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 69238-1060-01 Amneal 100 tablets $0.592 AB Availability likely
Chlorpromazine hydrochloride 100 mg 70710-1132-01 Zydus 100 tablets $0.592 AB Availability likely
Chlorpromazine Hydrochloride 100 mg 72205-0106-91 Novadoz 100 tablets $0.592 AB Availability likely
Chlorpromazine hydrochloride 100 mg 00904-7132-61 Major 1 tablet $0.598 AB Discontinued
ChlorproMAZINE Hydrochloride 100 mg 90096-0134-01 Zameer 100 tablets $0.874 AB FDA listed
Chlorpromazine 100 mgthis 46708-0738-31 Alembic 100 tablets AB FDA listed
Chlorpromazine Hydrochloride 100 mg 51407-0437-01 Golden 100 tablets AB FDA listed
Chlorpromazine Hydrochloride 100 mg 59651-0570-01 Aurobindo 100 tablets AB FDA listed
Chlorpromazine 100 mg 62332-0738-10 Alembic 1000 tablets AB FDA listed
Chlorpromazine Hydrochloride 100 mg 70518-3584-00 REMEDYREPACK 30 tablets AB Discontinued
Chlorpromazine Hydrochloride 100 mg 70518-4294-00 REMEDYREPACK 1 tablet AB FDA listed
Chlorpromazine hydrochloride 100 mg 70771-1509-01 Zydus 100 tablets AB FDA listed
Chlorpromazine 100 mg 70518-4724-00 REMEDYREPACK 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46708-0738-10 100 BLISTER PACK in 1 CARTON (46708-738-10) / 10 TABLET in 1 BLISTER PACK 2023-07-20 Active
46708-0738-31 You're viewing this 100 TABLET in 1 BOTTLE (46708-738-31) 2023-07-20 Active
46708-0738-91 1000 TABLET in 1 BOTTLE (46708-738-91) 2023-07-20 Active

Pack size FAQ

What quantity is in NDC 46708-0738-31?
NDC 46708-0738-31 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 46708-0738-31 and NDC 46708-0738-10?
Both are Chlorpromazine 100 mg Tablet — the drug itself is identical. NDC 46708-0738-31 is the 100-count package, while NDC 46708-0738-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Chlorpromazine 100 mg Tablet?
Bill NDC 46708-0738-31 — the 11-digit billing format is 46708073831. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 46708-738-31, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 46708-0738-31, written without dashes as 46708073831. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 46708-0738-31, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0738) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1000 tablets (46708-0738-10), 1000 tablets (46708-0738-91). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 184 words

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.

Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS ] .

🎯 Indications and Usage 122 words

INDICATIONS AND USAGE For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting.

For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus.

To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION – ADULTS Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients.

In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period. The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions. Elderly Patients - In general, dosages in the lower range are sufficient for most elderly patients.

Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

Psychotic Disorders - Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level.

Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients). Hospitalized Patients: Acute Schizophrenic or Manic States - It is recommended that initial treatment be with chlorpromazine HCl injection until patient is controlled.

Usually patient becomes quiet and co-operative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods.

In general, dosage levels should be lower in the elderly, the emaciated and the debilitated. Less Acutely Disturbed - 25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily.

Outpatients - 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d. More Severe Cases - 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semi-weekly intervals until patient becomes calm and cooperative.

Prompt Control of Severe Symptoms - Initial treatment should be with intramuscular chlorpromazine. Subsequent doses should be oral, 25 to 50 mg t.i.d. Nausea and Vomiting - 10 to 25 mg q4 to 6h, p.r.n., increased, if necessary.

Presurgical Apprehension - 25 to 50 mg, 2 to 3 hours before the operation. Intractable Hiccups - 25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral therapy is indicated.

Acute Intermittent Porphyria - 25 to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients. DOSAGE AND ADMINISTRATION – PEDIATRIC PATIENTS (6 months to 12 years of age) Chlorpromazine should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving.

It should not be used in conditions for which specific pediatric dosages have not been established. Severe Behavioral Problems Outpatients - Select route of administration according to severity of patient’s condition and increase dosage gradually as required. Oral: ¼ mg/lb body weight q4 to 6h, p.r.n.

(e.g., for 40 lb child – 10 mg q4 to 6h). Hospitalized Patients - As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders higher dosages (50 to 100 mg daily and in older children, 200 mg daily or more) may be necessary.

There is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced by doses beyond 500 mg per day. Nausea and Vomiting - Dosage and frequency of administration should be adjusted according to the severity of the symptoms…

Contraindications 33 words

CONTRAINDICATIONS Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).

⚠️ Warnings ~3 min read

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. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see BOXED WARNING] . The extrapyramidal symptoms which can occur secondary to chlorpromazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy.

The use of chlorpromazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome. Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with 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 antipsychotic treatment, which patients are likely to develop the syndrome.

Whether antipsychotic 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 antipsychotic 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 antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and therapy 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, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic 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 antipsychotics, 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 and ADVERSE REACTIONS. 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 ner…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Note: Some adverse effects of chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: Usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.

Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy.

The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported. There is no conclusive evidence that preexisting liver disease makes patients more susceptible to jaundice.

Alcoholics with cirrhosis have been successfully treated with chlorpromazine without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to chlorpromazine or other phenothiazines.

If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed.

Hematological Disorders: Including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported. Agranulocytosis - Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.

Most cases have occurred between the fourth and tenth weeks of therapy; patients should be watched closely during that period. Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above. Cardiovascular: Hypotensive Effects - Postural hypotension, simple tachycardia, momentary fainting and dizziness may occur rarely, after the first oral dose.

Usually recovery is spontaneous and symptoms disappear within ½ to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition. To control hypotension, place patient in head-low position with legs raised.

If a vasoconstrictor is required, norepinephrine and phenylephrine are the most suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure. EKG Changes - Particularly nonspecific, usually reversible Q and T wave distortions - have been observed in some patients receiving phenothiazine tranquilizers, including chlorpromazine.

Note: Sudden death, apparently due to cardiac arrest, has been reported. CNS Reactions: Extrapyramidal Symptoms - Neuromuscular reactions include dystonias, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following paragraphs: 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…

🆘 Overdosage ~1 min read

OVERDOSAGE [See also ADVERSE REACTIONS ] . Symptoms Primarily symptoms of central nervous system depression to the point of somnolence or coma. Hypotension and extrapyramidal symptoms.

Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus. EKG changes and cardiac arrhythmias. Treatment It is important to determine other medications taken by the patient since multiple drug therapy is common in overdosage situations.

Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage.

Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products.

Care should be taken to avoid increasing respiratory depression. If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.

If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure.

Limited experience indicates that phenothiazines are not dialyzable.

🧬 Clinical Pharmacology 75 words

CLINICAL PHARMACOLOGY The precise mechanism whereby the therapeutic effects of chlorpromazine are produced is not known. The principal pharmacological actions are psychotropic. It also exerts sedative and antiemetic activity.

Chlorpromazine has actions at all levels of the central nervous system –primarily at subcortical levels – as well as on multiple organ systems. Chlorpromazine has strong antiadrenergic and weaker peripheral anticholinergic activity; ganglionic blocking action is relatively slight. It also possesses slight antihistaminic and antiserotonin activity.

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Chlorpromazine hydrochloride tablets USP, 10 mg are round, white to off-white colored, biconvex, film-coated tablets, imprinted with “J” on one side and plain on the other side. They are supplied as follows: Bottles of 100 tablets with child-resistant closure, NDC 46708-735-31 Bottles of 1000 tablets, NDC 46708-735-91 Unit dose cartons of 100 tablets, 10 blisters of 10 tablets each, NDC 46708-735-10 Chlorpromazine hydrochloride tablets USP, 25 mg are round, white to off-white colored, biconvex, film-coated tablets, imprinted with “J2” on one side and plain on the other side.

They are supplied as follows: Bottles of 100 tablets with child-resistant closure, NDC 46708-736-31 Bottles of 1000 tablets, NDC 46708-736-91 Unit dose cartons of 100 tablets, 10 blisters of 10 tablets each, NDC 46708-736-10 Chlorpromazine hydrochloride tablets USP, 50 mg are round, brown colored, biconvex, film-coated tablets, imprinted with “J3” on one side and plain on the other side. They are supplied as follows: Bottles of 100 tablets with child-resistant closure, NDC 46708-737-31 Bottles of 1000 tablets, NDC 46708-737-91 Unit dose cartons of 100 tablets, 10 blisters of 10 tablets each, NDC 46708-737-10 THE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS.

Chlorpromazine hydrochloride tablets USP, 100 mg are round, brown colored, biconvex, film-coated tablets, imprinted with “J4” on one side and plain on the other side. They are supplied as follows: Bottles of 100 tablets with child-resistant closure, NDC 46708-738-31 Bottles of 1000 tablets, NDC 46708-738-91 Unit dose cartons of 100 tablets, 10 blisters of 10 tablets each, NDC 46708-738-10 Chlorpromazine hydrochloride tablets USP, 200 mg are round, brown colored, biconvex, film-coated tablets, imprinted with “J5” on one side and plain on the other side.

They are supplied as follows: Bottles of 100 tablets with child-resistant closure, NDC 46708-739-31 Bottles of 1000 tablets, NDC 46708-739-91 Unit dose cartons of 100 tablets, 10 blisters of 10 tablets each, NDC 46708-739-10 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. This package is not for household dispensing.

If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized. Keep out of reach of children. Rx only Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Revised: 08/2022

📋 Description 181 words

DESCRIPTION Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula: Chlorpromazine hydrochloride, USP occurs as white to creamy white, crystalline powder.

Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: lactose monohydrate, crospovidone, sodium starch glycolate (10 mg and 25 mg), microcrystalline cellulose (50 mg, 100 mg and 200 mg) and sodium lauryl sulfate (50 mg, 100 mg and 200 mg) povidone K-30, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol 6000 (10 mg and 25 mg) and polyethylene glycol 3350 (50 mg, 100 mg and 200 mg). Additionally, 50 mg, 100 mg and 200 mg strengths also contain polyvinyl alcohol, D&C Yellow #10 Aluminium Lake, D&C Red #30 Aluminium Lake, FD&C Blue #2 Aluminium Lake.

The tablets are imprinted with edible black ink. The edible black ink contains shellac, black iron oxide and propylene glycol. FDA approved dissolution test specifications differ from USP. structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.