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Cyproheptadine Hydrochloride 2 mg/5mL Solution, 473 mL — NDC 39328-544-16 (Billing 39328-0544-16)

by Patrin Pharma, Inc. · 473 mL in 1 BOTTLE, GLASS

This is a package of 473 mL of Cyproheptadine Hydrochloride 2 mg/5mL Solution from Patrin Pharma, Inc., marketed since Feb 2022 and currently FDA-listed; retail pharmacies pay about $0.0419 per mL (NADAC). It is this product's only package size.

NDC 39328-0544-16
🏷️ FDA NDC (as labeled) 39328-544-16 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

NDC database record

One package, one record: these facts belong to NDC 39328-544-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
39328 labeler · 544 product · 16 package
Package marketed since
Feb 15, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 3932854416 4
Medicaid fills, this package
9,502 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) 39328-544-16
Product NDC 39328-544
11-digit billing NDC 39328054416
NCPDP billing unit ML — per mL (volume)
RxCUI 866021
UNII 2YHB6175DO
Application # ANDA209108
SPL Set ID 81d9523f-f945-4410-8b71-8b5fea48a3da
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-15
Route ORAL
Dosage form SOLUTION
Substance CYPROHEPTADINE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 41500020101210
GCN Seq No 004010
GCN 15803
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 2 MG/5 ML SOLN
FDB brand name Cyproheptadine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004010
  • GCN: 15803
  • GPI-14 (Medi-Span): 41500020101210
  • HICL (First Databank): 001672
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 866021
Why two NDCs? The FDA registers this code as 39328-544-16 — 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 → 39328-0544-16. 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 2 MG/5 ML SOLN 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 mLPer package
Retail pharmacies payNADAC · weekly $0.042 $19.82 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.0711 $33.63 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.0807 $38.17 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.050 $0.041
▼ Down 16% over the last 13 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 Marketing startMarketing endStatus
39328-0544-16 You're viewing this Main listing 473 mL in 1 BOTTLE, GLASS 2022-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
cyproheptadine hydrochloride solution 2 mg/5mL 58657-0697-16 Method 473 ml $0.041 AA Availability likely save 2%
Cyproheptadine Hydrochloride 2 mg/5mL 70752-0101-12 QUAGEN 473 ml $0.041 AA Availability likely save 2%
Cyproheptadine Hydrochloride 2 mg/5mLthis 39328-0544-16 Patrin 473 ml $0.042 AA Availability likely —
Cyproheptadine 2 mg/5mL 62135-0949-47 Chartwell 473 ml $0.042 AA Availability likely —
Cyproheptadine Hydrochloride 2 mg/5mL 64980-0504-48 Rising 473 ml $0.042 AA Availability likely —
Cyproheptadine Hydrochloride 2 mg/5mL 70752-0185-12 QUAGEN 473 ml $0.042 AA Availability likely —
Cyproheptadine Hydrochloride 2 mg/5mL 17856-0504-01 Atlantic 120 syringes — AA FDA listed —
Cyproheptadine Hydrochloride 2 mg/5mL 27808-0099-01 Tris 473 ml — — FDA listed —
Cyproheptadine Hydrochloride 2 mg/5mL 72162-2065-02 Bryant 473 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

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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 Yellow
FlavorPeppermint
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

8 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

LabelerPatrin Pharma, Inc.
Application holderST JOHN PHARMACEUTICAL USA INC
FDA applicationANDA209108 (ANDA)
Labeler code39328
First marketedFeb 2022
Product typeHuman Prescription Drug
Portfolio18 products on file

More NDCs from Patrin Pharma, Inc. labeler code 39328

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 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 5 mL of Cyproheptadine Hydrochloride Oral Solution contains 2 mg of Cyproheptadine hydrochloride. Although intended primarily for administration to children, the oral solution is also used for administration to adults who cannot swallow tablets.

Children The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m 2 ). Age 2 to 6 years The usual dose is 2 mg (one teaspoonful) 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 (two teaspoonsful) 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 (0.23 mg/lb/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 (two teaspoonsful) 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 94 words ▾

WARNINGS Children Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions 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.

🤒 Adverse Reactions 134 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: 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.

To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088.

🔄 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 29 words ▾

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

🆘 Overdosage 178 words ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in children. 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 the patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or 1/2 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 139 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-labeled cyproheptadine HCl in normal subjects, given as tablets or oral solution, 2-20% 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 12-20 mg daily doses of cyproheptadine oral solution.

The principal 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 55 words ▾

HOW SUPPLIED Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL in a yellow, peppermint-flavored vehicle, is supplied in a 473 mL (16 FL. OZ.) bottle. Store at 20-25°C (68-77°F). Excursion permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. NDC#39328-544-16 473 mL (16 FL. OZ.)

📦 Storage and Handling 30 words ▾

Store at 20-25°C (68-77°F). Excursion permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. NDC#39328-544-16 473 mL (16 FL. OZ.)

📋 Description 111 words ▾

DESCRIPTION Each 5 mL (one teaspoonful) contains: Cyproheptadine Hydrochloride 2 mg Inactive Ingredients: Alcohol 5%, citric acid, D&C Yellow #10, flavors, purified water, sodium citrate, sorbic acid (0.1% as preservative) and sucrose. Cyproheptadine HCl is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a white to slightly yellowish, crystalline solid, with a molecular weight of 350.89, which is slightly 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-(5H-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: 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 in vitro ; 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 years have not been established. (See CONTRAINDICATIONS, Newborn or Premature Infants , and WARNINGS, Children .)

🍼 Nursing Mothers 64 words ▾

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 110 words ▾

Pharmacokinetics and Metabolism After a single 4 mg oral dose of 14 C-labeled cyproheptadine HCl in normal subjects, given as tablets or oral solution, 2-20% 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 12-20 mg daily doses of cyproheptadine oral solution. The principal 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 81 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 in vitro ; 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 35 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label Rx Only NDC 39328-544-16 Cyproheptadine Hydrochloride Oral Solution, USP 2 mg/5 mL 473 mL (16 FL. OZ.) PATRIN PHARMA PRINCIPAL DISPLAY PANEL - 473 mL Bottle 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
9.5K
Units reimbursed last 4 qtrs
2.3M
Gross reimbursed last 4 qtrs
$163.9K
Avg / prescription
$17.25
Avg / unit
$0.0711
Latest quarter Q1 2026
2.1KRx
Medicaid pays / mL
$0.0711
gross reimbursed
vs
NADAC / mL
$0.0419
acquisition cost
=
Spread
+$0.0292
+70% vs cost
What Medicaid paid per mL (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 ⓘ
49% FFS 51% MCO
Fee-for-service · 4,633 Rx Managed care · 4,869 Rx
State Medicaid map
Alaska: no data reported AK Maine: 50,177 units · 3,597 per 100k residents ME Washington: 16,432 units · 210 per 100k residents WA Idaho: 14,067 units · 716 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 76,602 units · 1,335 per 100k residents MN Wisconsin: 37,333 units · 632 per 100k residents WI Michigan: 33,110 units · 330 per 100k residents MI New York: 126,851 units · 648 per 100k residents NY Vermont: 11,488 units · 1,776 per 100k residents VT New Hampshire: no data reported NH Oregon: 5,472 units · 129 per 100k residents OR Nevada: 2,180 units · 68.3 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 53,083 units · 423 per 100k residents IL Indiana: no data reported IN Ohio: 37,556 units · 319 per 100k residents OH Pennsylvania: 13,395 units · 103 per 100k residents PA New Jersey: 51,152 units · 551 per 100k residents NJ Massachusetts: 49,340 units · 705 per 100k residents MA California: 383,837 units · 985 per 100k residents CA Utah: 18,864 units · 552 per 100k residents UT Colorado: 186,694 units · 3,176 per 100k residents CO Nebraska: 43,112 units · 2,180 per 100k residents NE Missouri: 26,719 units · 431 per 100k residents MO Kentucky: 59,860 units · 1,323 per 100k residents KY West Virginia: 34,990 units · 1,977 per 100k residents WV Virginia: 15,348 units · 176 per 100k residents VA Maryland: 25,844 units · 418 per 100k residents MD Connecticut: 14,549 units · 402 per 100k residents CT Rhode Island: 2,938 units · 268 per 100k residents RI Arizona: 113,033 units · 1,521 per 100k residents AZ New Mexico: 30,903 units · 1,462 per 100k residents NM Kansas: 10,146 units · 345 per 100k residents KS Arkansas: 2,025 units · 66.0 per 100k residents AR Tennessee: 101,431 units · 1,423 per 100k residents TN North Carolina: 104,707 units · 966 per 100k residents NC South Carolina: 13,959 units · 260 per 100k residents SC Delaware: 3,215 units · 312 per 100k residents DE Oklahoma: 6,754 units · 167 per 100k residents OK Louisiana: 77,314 units · 1,690 per 100k residents LA Mississippi: 32,461 units · 1,104 per 100k residents MS Alabama: 53,030 units · 1,038 per 100k residents AL Georgia: 17,322 units · 157 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 90,754 units · 298 per 100k residents TX Florida: 256,850 units · 1,136 per 100k residents FL
Units reimbursed · per 100k residents
66.03,597
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 Maine 3,597 /100k
2 Colorado 3,176 /100k
3 Nebraska 2,180 /100k
4 West Virginia 1,977 /100k
5 Vermont 1,776 /100k
6 Louisiana 1,690 /100k
7 Arizona 1,521 /100k
8 New Mexico 1,462 /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.
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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.