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Cyproheptadine Hydrochloride 4 mg Tablet, 1,000-count — NDC 50742-0190-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cyproheptadine Hydrochloride 4 mg Tablet, 1,000-count — NDC 50742-190-10 (Billing 50742-0190-10)

by Ingenus Pharmaceuticals LLC · 1000 TABLET in 1 BOTTLE, PLASTIC

This is a package of 1,000 tablets of Cyproheptadine Hydrochloride 4 mg Tablet from Ingenus Pharmaceuticals LLC, marketed since Sep 2015 and currently FDA-listed; retail pharmacies pay about $0.0902 per tablet (NADAC).

NDC 50742-0190-10
🏷️ FDA NDC (as labeled) 50742-190-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0902 NADAC Per package$90.20 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.2730/unit — full pricing hub ↓
Product page 50742-0190-01 Also comes in: 100 tablets 50742-190-01
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

NDC database record

One package, one record: these facts belong to NDC 50742-190-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50742 labeler · 190 product · 10 package
Package marketed since
Sep 23, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1,000 EA per package
Barcode (UPC-A, from the NDC)
3 5074219010 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Cyproheptadine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 13, 2026 — Presence of Precipitate: medication was crystallizing and particles floating in the bottle (Rising Pharma Holding, Inc.) · FDA recall D-0724-2026
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) 50742-190-10
Product NDC 50742-190
11-digit billing NDC 50742019010
NCPDP billing unit EA — each (per item)
RxCUI 866144
UNII NJ82J0F8QC
Application # ANDA205087
SPL Set ID 56f428c9-8d33-4c91-91d8-1fe194335066
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-23
Route ORAL
Dosage form TABLET
Substance CYPROHEPTADINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 41500020100305
GPI class Cyproheptadine HCl
GCN Seq No 004011
GCN 15811
HICL code 001672
Ingredient (HICL) Cyproheptadine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CYPROHEPTADINE 4 MG TABLET
FDB brand name Cyproheptadine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004011
  • GCN: 15811
  • GPI-14 (Medi-Span): 41500020100305
  • HICL (First Databank): 001672
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 866144
Why two NDCs? The FDA registers this code as 50742-190-10 — 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 → 50742-0190-10. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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 CYPROHEPTADINE 4 MG TABLET Ingredient Cyproheptadine Hcl
📗 Our plain-language guide HelloPharmacist
  • It's an antihistamine for allergy problems like hay fever, allergic eye irritation, hives and swelling. It can also be used after a severe allergic reaction is under control, along...
  • It often does, though the sleepiness may fade over time. Be careful driving or using machinery until you know how it affects you. Skip alcohol, since it adds to the drowsiness.
  • Be careful. Sleep aids, sedatives, tranquilizers and anti-anxiety medicines can add to the sedation. Please check with me or your doctor first.
  • Can I take it with my sleep or anxiety medicine?
📖 Read our full Cyproheptadine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.090 $90.20 / 1000 tablets
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 $0.2730 $273.00 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.098 $0.081
▲ Up 10% over the last 12 months.
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 Per unit Per pack Marketing startMarketing endStatus
50742-0190-01 50742-190-01 Main listing 100 TABLET in 1 BOTTLE, PLASTIC $0.0679 / ea $6.79 2015-09-23 — Active
50742-0190-10 You're viewing this 1000 TABLET in 1 BOTTLE, PLASTIC $0.0902 / ea $90.23 2015-09-23 — Active

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

Per ea, this pack runs about 33% above the cheapest pack (100-count, $0.0679 vs $0.0902 NADAC).

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle, plastic.
How does this package differ from NDC 50742-0190-01?
Both are Cyproheptadine Hydrochloride 4 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 50742-0190-01 is the 100 tablets package. Per-ea NADAC also differs: $0.0902 here vs $0.0679 for the 100 tablets pack.
What NDC number is used to bill for this package of Cyproheptadine Hydrochloride 4 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyproheptadine Hydrochloride 4 mg 00115-1757-01 Amneal 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 16571-0805-01 Rising 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 50268-0201-15 AvPAK 50 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 52817-0210-10 TRUPHARMA, 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 62135-0236-90 Chartwell 90 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 64380-0795-06 Strides 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 70710-1110-00 Zydus 1000 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 70752-0107-10 QUAGEN 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mg 76385-0130-01 UNICHEM 100 tablets $0.068 AA Availability likely save 25%
Cyproheptadine Hydrochloride 4 mgthis 50742-0190-10 Ingenus 1000 tablets $0.090 AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 42708-0177-21 QPharma 21 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 42708-0187-21 QPharma 21 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 50090-5491-01 A-S 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 50090-6129-01 A-S 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 51407-0272-10 Golden 1000 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 70518-3517-00 REMEDYREPACK 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 70518-4667-00 REMEDYREPACK 50 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 70771-1076-00 Zydus 1000 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 71335-1107-01 Bryant 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 71335-2368-01 Bryant 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 71335-2453-01 Bryant 30 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 71335-2964-01 Bryant 90 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 72162-2066-00 Bryant 1000 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 72789-0102-01 PD-Rx 100 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 52817-0415-10 TRUPHARMA, 100 tablets — AA FDA listed —
Cyproheptadine Hydrochloride 4 mg 71335-0211-01 Bryant 30 tablets — 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color White
ShapeRound
Imprint49
Size7 mm
ScoringScored — splits in 2
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.

🧪 Avoiding an ingredient? See Cyproheptadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerIngenus Pharmaceuticals LLC
Application holderINGENUS PHARMACEUTICALS LLC
FDA applicationANDA205087 (ANDA)
Labeler code50742
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Ingenus Pharmaceuticals LLC labeler code 50742

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

INDICATIONS AND USAGE Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Each tablet contains 4 mg of cyproheptadine hydrochloride. Pediatric Patients Age 2 to 6 years The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m 2 ).

The usual dose is 2 mg (½ tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day. Age 7 to 14 years The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient.

The dose is not to exceed 16 mg a day. Adults The total daily dose for adults should not exceed 0.5 mg/kg/day. The therapeutic range is 4 mg to 20 mg a day, with the majority of patients requiring 12 mg to 16 mg a day.

An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.

⛔ Contraindications 78 words ▾

CONTRAINDICATIONS Newborn or Premature Infants This drug should not be used in newborn or premature infants. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Other Conditions Hypersensitivity to cyproheptadine and other drugs of similar chemical structure.

Monoamine oxidase inhibitor therapy (See DRUG INTERACTIONS .) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients

⚠️ Warnings 105 words ▾

WARNINGS Pediatric Patients Overdosage of antihistamines, particularly in infants and young children, may produce hallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, and death. Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. CNS Depressants Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients (see PRECAUTIONS, Geriatric Use ).

🤒 Adverse Reactions 146 words ▾

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals NJ, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.

Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock.

Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Genitourinary Urinary frequency, difficult urination, urinary retention, early menses.

Respiratory Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous Fatigue, chills, headache, increased appetite/weight gain.

🔄 Drug Interactions 29 words ▾

Drug Interactions MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

🤰 Pregnancy 129 words ▾

Pregnancy Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. Two studies in pregnant women, however, have not shown that cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy.

No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of two have not been established (see CONTRAINDICATIONS, Newborn or Premature Infants , and WARNINGS, Pediatric Patients ).

Pediatric Patients Age 2 to 6 years The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m 2 ). The usual dose is 2 mg (½ tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day.

Age 7 to 14 years The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day. Adults The total daily dose for adults should not exceed 0.5 mg/kg/day.

The therapeutic range is 4 mg to 20 mg a day, with the majority of patients requiring 12 mg to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.

🧓 Geriatric Use 91 words ▾

Geriatric Use Clinical studies of cyproheptadine HCl tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS, Activities Requiring Mental Alertness ).

🆘 Overdosage 181 words ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in pediatric patients. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.) as well as gastrointestinal symptoms may occur. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac.

If patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or ½ isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children.

When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered. Dosage and frequency of administration are dependent on age, clinical response, and recurrence after response. (See package circulars for physostigmine products.) Saline cathartics , as milk of magnesia, by osmosis draw water into the bowel and, therefore, are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used . Vasopressors may be used to treat hypotension. The oral LD 50 of cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively.

🧬 Clinical Pharmacology 136 words ▾

CLINICAL PHARMACOLOGY Cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. Antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites. Pharmacokinetics and Metabolism After a single 4 mg oral dose of 14 C-labelled cyproheptadine HCl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools.

Only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. At least 40% of the administered radioactivity was excreted in the urine. No detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses.

The principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. Elimination is diminished in renal insufficiency.

📦 How Supplied / Storage and Handling 107 words ▾

HOW SUPPLIED Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off- white, round, flat-faced, beveled-edged tablets, debossed “4” on left side, “9” on right side of the scoring on one side and plain on the other side, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 (NDC 50742-190-01) and 1000 (NDC 50742-190-10) tablets. Tablets have functional scoring. PHARMACIST: Dispense in a well-closed container as defined in the USP with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured For: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 Rx Only 551702 Rev. 01/2025 5517 logo

📋 Description 108 words ▾

DESCRIPTION Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5 H -dibenzo [a,d] cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride.

The molecular formula of the anhydrous salt is C 21 H 21 N•HCl and the structural formula of the anhydrous salt is: Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Chemical Structure

💬 Information for Patients 41 words ▾

Information for Patients Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Cyproheptadine has an atropine-like action and, therefore, should be used with caution in patients with: History of bronchial asthma Increased intraocular pressure Hyperthyroidism Cardiovascular disease Hypertension Information for Patients Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.

Drug Interactions MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies have not been done with cyproheptadine.

Cyproheptadine had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose. Cyproheptadine did not produce chromosome damage in human lymphocytes or fibroblasts invitro ; high doses (10 -4 M) were cytotoxic. Cyproheptadine did not have any mutagenic effect in the Ames microbial mutagen test; concentrations of above 500 mcg/ plate inhibited bacterial growth.

Pregnancy Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. Two studies in pregnant women, however, have not shown that cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy.

No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from cyproheptadine, 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 (see CONTRAINDICATIONS ). Pediatric Use Safety and effectiveness in pediatric patients below the age of two have not been established (see CONTRAINDICATIONS, Newborn or Premature Infants , and WARNINGS, Pediatric Patients ). Geriatric Use Clinical studies of cyproheptadine HCl tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS, Activities Requiring Mental Alertness ).

🍼 Nursing Mothers 90 words ▾

Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from cyproheptadine, 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 (see CONTRAINDICATIONS ).

🧬 Pharmacokinetics 107 words ▾

Pharmacokinetics and Metabolism After a single 4 mg oral dose of 14 C-labelled cyproheptadine HCl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools. Only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. At least 40% of the administered radioactivity was excreted in the urine.

No detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses. The principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. Elimination is diminished in renal insufficiency.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 82 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies have not been done with cyproheptadine. Cyproheptadine had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose. Cyproheptadine did not produce chromosome damage in human lymphocytes or fibroblasts invitro ; high doses (10 -4 M) were cytotoxic.

Cyproheptadine did not have any mutagenic effect in the Ames microbial mutagen test; concentrations of above 500 mcg/ plate inhibited bacterial growth.

📄 Package Label / Principal Display Panel 60 words ▾

Package Label - Principal Display Panel – 4 mg, 100 Tablets Label ingenus NDC 50742-190-01 Cyproheptadine HCI Tablets, USP 4 mg Rx only 100 Tablets 4 mg, 100 Tablets Label

Package Label - Principal Display Panel – 4 mg, 1000 Tablets Label ingenus NDC 50742-190-10 Cyproheptadine HCI Tablets, USP 4 mg Rx only 1000 Tablets 4 mg, 1000 Tablets Label

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

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.
100 tablets50742-0190-01 54,446 Rx · $560,137
1000 tablets this page50742-0190-10 No Medicaid data
Drug total (last 4 qtrs): 54,446 Rx · 2,730,972 units · $560,137 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 50742-0184-25 · Ingenus 50742-0191-01 · Ingenus →
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.