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Cyproheptadine Hydrochloride 4 mg Tablet, 1,000-count — NDC 64380-0795-08 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 64380-795-08 (Billing 64380-0795-08)

by Strides Pharma Science Limited · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Cyproheptadine Hydrochloride 4 mg Tablet from Strides Pharma Science Limited, marketed since Apr 2018 and currently FDA-listed; retail pharmacies pay about $0.0679 per tablet (NADAC).

NDC 64380-0795-08
🏷️ FDA NDC (as labeled) 64380-795-08 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0679 NADAC Per package$67.90 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2096/unit · Part D plans $0.2730/unit — full pricing hub ↓
Product page 64380-0795-06 Also comes in: 100 tablets 64380-795-06
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 64380-795-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64380 labeler · 795 product · 08 package
Package marketed since
Apr 11, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1,000 EA per package
Barcode (UPC)
0364380795063
Medicaid fills, this package
1,085 prescriptions in the last four reported quarters
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) 64380-795-08
Product NDC 64380-795
11-digit billing NDC 64380079508
NCPDP billing unit EA — each (per item)
RxCUI 866144
UNII NJ82J0F8QC
UPC 0364380795063
Application # ANDA209172
SPL Set ID b28c2ca0-140d-44d8-a59e-75fbfe8eabdd
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-11
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 64380-795-08 — 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 → 64380-0795-08. 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
📖 What it is MedlinePlus · NLM

Cyproheptadine is used to treat allergy symptoms: runny nose sneezing tching of the nose or throat red, itchy, or watery eyes It may also be used to relieve the itching of allergic skin conditions and to treat hives. Cyproheptadine is also used to treat severe or life-threatening allergic reactions. Cyproheptadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 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 $0.068 $67.90 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.2096 $209.60 / 1000 tablets
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.107 $0.064
▼ Down 22% over the last 24 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
64380-0795-06 64380-795-06 Main listing 100 TABLET in 1 BOTTLE $0.0679 / ea $6.79 2018-04-11 — Active
64380-0795-08 You're viewing this 1000 TABLET in 1 BOTTLE $0.0679 / ea $67.87 2018-04-11 — Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0679 NADAC).

This pack accounts for about 36% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 64380-0795-06?
Both are Cyproheptadine Hydrochloride 4 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 64380-0795-06 is the 100 tablets package.
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 —
Cyproheptadine Hydrochloride 4 mg 16571-0805-01 Rising 100 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 50268-0201-15 AvPAK 50 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 50742-0190-01 Ingenus 100 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 52817-0210-10 TRUPHARMA, 100 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 62135-0236-90 Chartwell 90 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mgthis 64380-0795-08 Strides 1000 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 70710-1110-00 Zydus 1000 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 70752-0107-10 QUAGEN 100 tablets $0.068 AA Availability likely —
Cyproheptadine Hydrochloride 4 mg 76385-0130-01 UNICHEM 100 tablets $0.068 AA Availability likely —
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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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
ImprintC4
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

4 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

LabelerStrides Pharma Science Limited
Application holderSTRIDES PHARMA INTERNATIONAL AG
FDA applicationANDA209172 (ANDA)
Labeler code64380
First marketedApr 2018
Product typeHuman Prescription Drug
Portfolio195 products on file

More NDCs from Strides Pharma Science Limited labeler code 64380

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 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 219 words ▾

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 to 20 mg a day, with the majority of patients requiring 12 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 106 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 157 words ▾

ADVERSE REACTIONS 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.

Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 182 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 110 words ▾

HOW SUPPLIED Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08 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 By: Strides Pharma Science Limited Bengaluru - 562106, India. Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807 Revised: 09/2025

📋 Description 116 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: C 21 H 21 N• HCl M.W. 350.89 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 (potato).

Structure

⚠️ 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 ).

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL Cyproheptadine HCl Tablets 4 mg 100s Label Text NDC 64380 -795- 06 CYPROHEPTADINE HCL Tablets USP 4 mg Rx only 100 TABLETS Strides Pharma Science Limited 100s container label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
55.7K
Gross reimbursed last 4 qtrs
$11.7K
Avg / prescription
$10.76
Avg / unit
$0.2096
Latest quarter Q1 2026
224Rx
Medicaid pays / ea
$0.2096
gross reimbursed
vs
NADAC / ea
$0.0679
acquisition cost
=
Spread
+$0.1417
+209% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 408 Rx Managed care · 677 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 870 units · 14.7 per 100k residents WI Michigan: 6,768 units · 67.4 per 100k residents MI New York: 13,849 units · 70.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 3,119 units · 24.1 per 100k residents PA New Jersey: 7,905 units · 85.1 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,085 units · 46.1 per 100k residents KY West Virginia: 3,135 units · 177 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,763 units · 126 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 10,917 units · 99.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,290 units · 4.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2177
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 177 /100k
2 Louisiana 126 /100k
3 Georgia 99.0 /100k
4 New Jersey 85.1 /100k
5 New York 70.8 /100k
6 Michigan 67.4 /100k
7 Kentucky 46.1 /100k
8 Pennsylvania 24.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 tablets64380-0795-06 1,963 Rx · $22,959
1000 tablets this page64380-0795-08 1,085 Rx · $11,677
Drug total (last 4 qtrs): 3,048 Rx · 153,061 units · $34,636 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 64380-0791-01 · Strides 64380-0796-04 · Strides →
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.