HomeNDC LookupIngredientsFluphenazine Hydrochloride › 16571-0892-50
Fluphenazine Hydrochoride fluphenazine hydrochloride 10 mg Tablet, Film Coated, 500-count — NDC 16571-0892-50 package photo

Fluphenazine Hydrochoride fluphenazine hydrochloride 10 mg Tablet, Film Coated, 500-count

by Rising Pharma Holdings, Inc. · 500 TABLET, FILM COATED in 1 CONTAINER (16571-892-50)
NDC 16571-0892-50
🏷️ FDA NDC (as labeled) 16571-892-50 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also comes in: 90 tablets 16571-0892-09
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 →
⚠️
Other active recalls for Fluphenazine Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0326-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0327-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 16571-892-50
Product NDC 16571-892
11-digit billing NDC 16571089250
NCPDP billing unit EA — each (per item)
UNII ZOU145W1XL
Application # ANDA218283
SPL Set ID 9fd44ab9-79bb-472e-8434-c3d786b42de5
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 2024-06-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance FLUPHENAZINE HYDROCHLORIDE
GPI-14 59200025100320
GCN Seq No 003824
GCN 14603
HICL code 001626
Ingredient (HICL) Fluphenazine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2G
Therapeutic class — specific (HIC3) Antipsychotics,Phenothiazines
AHFS code 28:16.08.24
AHFS class Phenothiazines
FDB label name FLUPHENAZINE 10 MG TABLET
FDB brand name Fluphenazine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 16571-892-50 — 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 → 16571-0892-50. 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 piperazine structure
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

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA218283 (ANDA)
Labeler code16571
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio525 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

Label name FLUPHENAZINE 10 MG TABLET Ingredient Fluphenazine Hcl
📖 What it is MedlinePlus · NLM

Fluphenazine is an antipsychotic medication used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility. Fluphenazine is in a class of medications called antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Fluphenazine is an antipsychotic medication used to manage psychotic disorders — most commonly schizophrenia. It's available as tablets, an oral liquid, and injections. The long-ac...
  • Fluphenazine Decanoate Injection is chemically designed to release slowly after a single shot, so one injection can keep working for up to four weeks or even longer. The regular ta...
  • How is the long-acting injection different from the tablets or regular shot?
  • The most common side effects involve movement — things like muscle stiffness, a restless, fidgety feeling, or tremors. These can often be managed by adjusting your dose or adding a...
📖 Read our full Fluphenazine guide →
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 / Blue / Pink / Orange
ShapeRound
ImprintC85
Size1 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 90 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
Fluphenazine Hydrochloride 10 mg 00527-1791-01 Lannett 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 00832-6006-11 Upsher-Smith 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 00904-7160-61 Major 1 tablet $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 24979-0139-01 Upsher-Smith 100 tablets $0.380 Availability likely
Fluphenazine hydrochloride 10 mg 27241-0252-01 Ajanta 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 31722-0387-01 Camber 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 43598-0037-01 Dr. 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 50268-0369-15 AvPAK 1 tablet $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 51672-4236-01 Sun 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 59651-0689-01 Aurobindo 100 tablets $0.380 Availability likely
Fluphenazine Hydrochloride 10 mg 60687-0761-01 American 1 tablet $0.380 AB Availability likely
fluphenazine hydrochloride 10 mg 62135-0419-90 Chartwell 90 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 62332-0791-31 Alembic 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 68462-0338-01 Glenmark 100 tablets $0.380 AB Availability likely
fluphenazine hydrochloride 10 mg 69238-1681-01 Amneal 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 70710-1491-01 Zydus 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 70954-0276-10 ANI 100 tablets $0.380 AB Availability likely
Fluphenazine Hydrochloride 10 mg 90096-0124-01 Zameer 100 tablets $0.498 AB FDA listed
Fluphenazine Hydrochloride 10 mg 10135-0728-01 Marlex 100 tablets AB FDA listed
Fluphenazine Hydrochoride 10 mgthis 16571-0892-50 Rising 500 tablets AB FDA listed
Fluphenazine Hydrochloride 10 mg 46708-0791-31 Alembic 100 tablets AB FDA listed
Fluphenazine Hydrochloride 10 mg 51407-0461-01 Golden 100 tablets AB FDA listed
Fluphenazine Hydrochloride 10 mg 70518-4673-00 REMEDYREPACK 1 tablet AB FDA listed
Fluphenazine Hydrochloride 10 mg 70771-1584-01 Zydus 100 tablets AB FDA listed
Fluphenazine Hydrochloride 10 mg 71205-0840-00 Proficient 100 tablets FDA listed
Fluphenazine Hydrochloride 10 mg 72205-0115-05 Novadoz 500 tablets AB FDA listed
Fluphenazine Hydrochoride 10 mg 70518-4691-00 REMEDYREPACK 1 tablet AB FDA listed
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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 49 Rx · 3,064 units · $2,725 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluphenazine Hydrochoride (this brand).

Top reported reactions

Sedation19
Anxiety13
Suicide Attempt12
Schizophrenia11
Blood Pressure Decreased10
Blood Pressure Increased10
Chest Pain10

Reporter sex

112 reports

Serious outcomes

Hospitalization47
Death9
Life-threatening6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
16571-0892-09 90 TABLET, FILM COATED in 1 CONTAINER (16571-892-09) $0.3798 / ea $34.18 2024-06-07 Active
16571-0892-50 You're viewing this 500 TABLET, FILM COATED in 1 CONTAINER (16571-892-50) 2024-06-07 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 16571-0892-50?
NDC 16571-0892-50 is a 500-count package — 500 tablet, film coated in 1 container.
What is the difference between NDC 16571-0892-50 and NDC 16571-0892-09?
Both are Fluphenazine Hydrochoride fluphenazine hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. NDC 16571-0892-50 is the 500-count package, while NDC 16571-0892-09 is the 90 tablets package.
What NDC number is used to bill for this package of Fluphenazine Hydrochoride fluphenazine hydrochloride 10 mg Tablet, Film Coated?
Bill NDC 16571-0892-50 — the 11-digit billing format is 16571089250. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 16571-892-50, 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: 16571-0892-50, written without dashes as 16571089250. 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 16571-0892-50, the first segment (16571) is the labeler code FDA assigned to Rising Pharma Holdings, Inc.; the middle segment (0892) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Rising Pharma Holdings, Inc.. 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 1 other package presentation of this same product, including 90 tablets (16571-0892-09). 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?
Rising Pharma Holdings, Inc. 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 Incr eased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

🎯 Indications and Usage 34 words

INDICATIONS & USAGE Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.

⏱️ Dosage and Administration ~1 min read

DOSAGE & ADMINISTRATION Depending on severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mg to 10 mg and should be divided and given at 6 to 8 hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately 2 to 3 times the parenteral dose of fluphenazine.

Treatment is best instituted with a low initial dosage , which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage.

Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 mg to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient’s requirements.

For psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the long-acting fluphenazine decanoate may be indicated (see package insert for fluphenazine decanoate for conversion information). For geriatric patients, the suggested starting dose is 1 mg to 2.5 mg daily, adjusted according to the response of the patient.

Contraindications 59 words

CONTRAINDICATIONS Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

⚠️ Warnings ~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. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (antipsychotic) drugs.

Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase.

However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process.

The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to neuroleptic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.

In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered.

However, some patients may require treatment despite the presence of the syndrome. (For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS , Information for Patients and ADVERSE REACTIONS , Tardive Dyskinesia .) Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and, 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no…

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS Central Nervous System: The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below ). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants.

Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoate injection, and by subsequent reduction in dosage. Extrapyramidal Symptoms: Dystonia: Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.

Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Tardive Dyskinesia: See WARNINGS . The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely.

The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder.

This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome. Other CNS Effects: Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy (see WARNINGS , Neuroleptic Malignant Syndrome ); leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS. Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts.

As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered. Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams. Autonomic Nervous System: Hypertension and fluctuations in blood pressure have been reported with fluphenazine hydrochloride.

Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately.

Norepinephrine Bitartrate Injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure. Autonomic reactions including nausea and…

🧬 Clinical Pharmacology 31 words

CLINICAL PHARMACOLOGY Fluphenazine hydrochloride has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.

📦 How Supplied / Storage and Handling 212 words

HOW SUPPLIED Fluphenazine Hydrochloride Tablets, USP are available as follows: 1 mg tablets are round shaped, white, film-coated tablets, debossed with “C” on one side and “101” on the other side. They are supplied in: Bottles of 90 (NDC 16571-889-09) Bottles of 500 (NDC 16571-889-50) 2.5 mg tablets are round shaped, blue, film-coated tablets, debossed with “C” on one side and “102” on the other side. They are supplied in: Bottles of 90 (NDC 16571-890-09) Bottles of 500 (NDC 16571-890-50) 5 mg tablets are round shaped, pink, film-coated tablets, debossed with “C” on one side and “103” on the other side.

They are supplied in: Bottles of 90 (NDC 16571-891-09) Bottles of 500 (NDC 16571-891-50) 10 mg tablets are round shaped, orange, film-coated tablets, debossed with “C85” on one side and plain on the other side. They are supplied in: Bottles of 90 (NDC 16571-892-09) Bottles of 500 (NDC 16571-892-50) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat.

Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Manufactured for: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Made in India Neutral code: 4323147/TS/DRUGS/2025 Revised: 09/2025 PIR89250-04

📋 Description 115 words

DESCRIPTION Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below: F luphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet.

Each tablet also contains calcium phosphate dibasic dihydrate, D&C Red #27 (2.5 mg and 5 mg only), D&C Red #30 (5 mg only), FD&C Blue #1 (5 mg only), FD&C Blue #2 (2.5 mg only), FD&C Red #40 (10 mg only), FD&C Yellow #6 (10 mg only), hypromellose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, polysorbate 80, purified water and titanium dioxide. fluphenazine-hydrochloride-struc.jpg

💬 Information for Patients ~1 min read

Information for Patients: Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided. Abrupt Withdrawal: In general, phenothiazines do not produce psychic dependence; however, gastritis, nausea and vomiting, dizziness, and tremulousness have been reported following abrupt cessation of high dose therapy.

Reports suggest that these symptoms can be reduced if concomitant antiparkinsonian agents are continued for several weeks after the phenothiazine is withdrawn. Facilities should be available for periodic checking of hepatic function, renal function and the blood picture. Renal function of patients on long-term therapy should be monitored; if BUN (blood urea nitrogen) becomes abnormal, treatment should be discontinued.

As with any phenothiazine, the physician should be alert to the possible development of “silent pneumonias” in patients under treatment with fluphenazine hydrochloride. Leukopenia, Neutropenia and Agranulocytosis: In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including fluphenazine hydrochloride USP. Agranulocytosis (including fatal cases) has also been reported.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue fluphenazine hydrochloride USP at the first sign of a decline in WBC in the absence of other causative factors. Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.

Patients with severe neutropenia (absolute neutrophil count <1000/mm 3 ) should discontinue fluphenazine hydrochloride USP and have their WBC followed until recovery.

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.