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Chlorpromazine Hydrochloride 30 mg/mL Concentrate, 120 mL — NDC 71656-0102-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorpromazine Hydrochloride 30 mg/mL Concentrate, 120 mL — NDC 71656-102-04 (Billing 71656-0102-04)

by Saptalis Pharmaceuticals, LLC. · 120 mL in 1 BOTTLE, PLASTIC

This is a package of 120 mL of Chlorpromazine Hydrochloride 30 mg/mL Concentrate from Saptalis Pharmaceuticals, LLC., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 71656-0102-04
🏷️ FDA NDC (as labeled) 71656-102-04 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Chlorpromazine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0634-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0630-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0637-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0633-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0632-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0639-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71656-102-04
Product NDC 71656-102
11-digit billing NDC 71656010204
NCPDP billing unit ML — per mL (volume)
RxCUI 991053, 991332
UNII 9WP59609J6
Application # ANDA080983
SPL Set ID cd8f9e23-d08a-4d96-8fe9-35ab2bc861c8
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 2026-03-04
Route ORAL
Dosage form CONCENTRATE
Substance CHLORPROMAZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 59200015101305
GCN Seq No 003795
GCN 14391
HICL code 001621
Ingredient (HICL) Chlorpromazine 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 CHLORPROMAZINE 30 MG/ML CONC
FDB brand name Chlorpromazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003795
  • GCN: 14391
  • GPI-14 (Medi-Span): 59200015101305
  • HICL (First Databank): 001621
  • AHFS class code: 28:16.08.24
  • RxCUI (RxNorm): 991053
Why two NDCs? The FDA registers this code as 71656-102-04 — 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 → 71656-0102-04. 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.

Clinical

Label name CHLORPROMAZINE 30 MG/ML CONC Ingredient Chlorpromazine Hcl
📖 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
  • 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 o...
  • 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...
  • 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...
  • 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,...
📖 Read our full Chlorpromazine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 Full Chlorpromazine nutrient depletion report →
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.

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 mLPer 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 $3.76 $450.65 / 120 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71656-0102-04 You're viewing this Main listing 120 mL in 1 BOTTLE, PLASTIC 2026-03-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorpromazine Hydrochloride 30 mg/mL 00781-4027-53 Sandoz, 120 ml — AA FDA listed —
Chlorpromazine Hydrochloride 30 mg/mLthis 71656-0102-04 Saptalis 120 ml — AA FDA listed —
chlorpromazine hydrochloride 30 mg/mL 72888-0457-01 Advagen 120 ml — AA 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

13 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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerSaptalis Pharmaceuticals, LLC.
Application holderSAPTALIS PHARMACEUTICALS LLC
FDA applicationANDA080983 (ANDA)
Labeler code71656
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio11 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.

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 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 183 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 122 words ▾

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.

DOSAGE AND ADMINISTRATION – PEDIATRIC PATIENTS (6 MONTHS TO 12 YEARS OF AGE) Chlorpromazine hydrochloride 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.

⛔ 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 98 words ▾

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 hydrochloride 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 hydrochloride and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Note : Some adverse effects of chlorpromazine hydrochloride 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 pre-existing liver disease makes patients more susceptible to jaundice.

Alcoholics with cirrhosis have been successfully treated with chlorpromazine hydrochloride 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 hydrochloride 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.

🤰 Pregnancy 105 words ▾

Usage in Pregnancy Safety for the use of chlorpromazine hydrochloride during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards.

There are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines. Reproductive studies in rodents have demonstrated potential for embryotoxicity, increased neonatal mortality and nursing transfer of the drug. Tests in the offspring of the drug-treated rodents demonstrate decreased performance.

The possibility of permanent neurological damage cannot be excluded.

🆘 Overdosage 6 words ▾

OVERDOSAGE (See also ADVERSE REACTIONS .)

🧬 Clinical Pharmacology 75 words ▾

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

Chlorpromazine hydrochloride has actions at all levels of the central nervous system-primarily at subcortical levels-as well as on multiple organ systems. Chlorpromazine hydrochloride 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 52 words ▾

HOW SUPPLIED Intended for institutional use only. Chlorpromazine Hydrochloride Oral Concentrate, USP is supplied as follows: 30 mg/mL : clear colorless to pale yellow, cherry flavored liquid in bottles of 120 mL NDC 71656-102-04 100 mg/mL : clear colorless to pale yellow, cherry flavored liquid in bottles of 240 mL NDC 71656-101-08

📦 Storage and Handling 40 words ▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Protect from light. Dispense in a tight, amber PET bottle. Never dispense in a flint, green, or blue bottle.

📋 Description 89 words ▾

DESCRIPTION Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino)propyl] phenothiazine monohydrochloride. It has the following structural formula: Chlorpromazine hydrochloride occurs as white or slightly creamy white, odorless, crystalline powder which darkens on prolonged exposure to light. Each mL of clear colorless to pale yellow solution, for oral administration, contains 30 mg or 100 mg chlorpromazine hydrochloride.

Inactive Ingredients: ascorbic acid, artificial cherry flavor, citric acid, edetate disodium, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, saccharin sodium, sodium citrate, sodium metabisulfite and sucrose. Chemical Structure

⚠️ Precautions 1 words ▾

PRECAUTIONS

🍼 Nursing Mothers 56 words ▾

Nursing Mothers There is evidence that chlorpromazine hydrochloride is excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from chlorpromazine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - 30mg/mL, 120 mL Bottle Label NDC 71656-102-04 chlorproMAZINE Hydrochloride Oral Concentrate, USP 30 mg/mL Rx only 120 mL container label

PRINCIPAL DISPLAY PANEL - 100mg/mL, 240 mL Bottle Label NDC 71656-101-08 chlorproMAZINE Hydrochloride Oral Concentrate, USP 100 mg/mL Rx only 240 mL image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Chlorpromazine hydrochloride — the ingredient across all brands.

Top reported reactions

Toxicity To Various Agents96
Overdose51
Drug Interaction37
Neuroleptic Malignant Syndrome37
Drug Abuse36
Somnolence36
Foetal Exposure During Pregnancy30

Age at onset

Neonate13
Child2
Adolescent8
Adult104
Elderly35

Reporter sex

944 reports
Male · 54%
Female · 46%
Unknown · 1%

Serious outcomes

Hospitalization391
Death139
Life-threatening60
Disabling11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 70 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Saptalis Pharmaceuticals, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Saptalis Pharmaceuticals, LLC. 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.
← 71656-0101-08 · Saptalis 71662-0000-01 · Transfer →
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.