Hydroxyzine Hydrochloride 50 mg Tablet, Film Coated, 100-count
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antihistamine class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Hydroxyzine is used to relieve itching caused by allergic skin reactions, to relieve anxiety and tension, and as a sedative before and after general anesthesia for surgery. Hydroxyzine 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. It also works by decreasing activity in the brain.
Read the full MedlinePlus article ↗- Hydroxyzine is most often used to relieve anxiety and tension, or to control itching from allergic conditions like hives or eczema. It's also used as a calming medication before su...
- Drowsiness is the most common side effect — it's actually how the medication works, so some sleepiness is expected, especially when you first start. For most people it gets better...
- This is really important to go over with your pharmacist or doctor, because hydroxyzine interacts with a number of common drugs. Combining it with alcohol, opioid pain medicines, s...
- Can I take hydroxyzine with my other medications?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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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.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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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.
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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.
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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.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
15 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.058 | $5.83 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1936 | $19.36 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1378 | $13.78 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride 50 mg 00093-5062-01 | Teva | 100 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 00904-6618-61 | Major | 1 tablet | $0.058 | AB | Availability likely | — |
| Hydroxyzine hydrochloride 50 mg 00904-7379-40 | Major | 500 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 16571-0115-01 | Rising | 100 tablets | $0.058 | AB | Availability likely | — |
| HydrOXYzine Hydrochloride 50 mg 16714-0083-10 | Northstar | 100 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine hydrochloride 50 mg 23155-0502-01 | Heritage | 100 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 24658-0783-10 | PURACAP | 1000 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mgthis 42806-0161-01 | Epic | 100 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 59651-0501-01 | Aurobindo | 100 tablets | $0.058 | — | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 60687-0875-01 | American | 1 tablet | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 62135-0575-05 | Chartwell | 500 tablets | $0.058 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 10702-0012-01 | KVK-Tech, | 100 tablets | $0.068 | AB | FDA listed | +17% |
| Hydroxyzine hydrochloride 50 mg 00615-8564-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 10135-0812-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 11534-0206-01 | Sunrise | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 31722-0502-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 43063-0519-30 | PD-Rx | 30 tablets | — | — | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 43063-0779-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 43063-0963-01 | PD-Rx | 100 tablets | — | — | FDA listed | — |
| HydrOXYzine Hydrochloride 50 mg 50090-2614-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 50090-6293-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 51407-0971-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 51655-0119-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 51655-0467-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 62135-0547-05 | Chartwell | 500 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 63187-0354-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 63629-4929-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 65162-0577-10 | Amneal | 100 tablets | — | — | FDA listed | — |
| HydrOXYzine Hydrochloride 50 mg 67296-2224-01 | Redpharm | 10 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 68071-5133-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 68071-5291-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 70518-1265-01 | REMEDYREPACK | 60 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 70518-4170-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71205-0083-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71205-0332-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-0246-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-2185-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-2410-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-3036-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72162-2167-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72162-2513-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine HCL 50 mg 72189-0577-60 | Direct_rx | 60 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72789-0269-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 72789-0378-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 76420-0883-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine HCL 50 mg 80425-0173-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 80425-0376-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 80425-0394-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 87441-0039-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 70518-0487-01 | REMEDYREPACK | 90 tablets | — | AB | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 42806-0161-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (42806-161-01) | $0.0583 / ea | $5.83 | 2015-03-31 | Active |
| 42806-0161-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42806-161-05) | $0.0583 / ea | $29.16 | 2015-03-31 | Active |
| 42806-0161-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-161-10) | $0.0583 / ea | $58.31 | 2015-03-31 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0583 NADAC).
This pack accounts for about 45% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 42806-0161-01?
What is the difference between NDC 42806-0161-01 and NDC 42806-0161-05?
What NDC number is used to bill for this package of Hydroxyzine Hydrochloride 50 mg Tablet, Film Coated?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.
Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.
The physician should reassess periodically the usefulness of the drug for the individual patient.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.
⛔ Contraindications ▾
CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range.
Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
⚠️ Warnings ▾
WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose.
Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes.
In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: Allergic reaction. Nervous System: Headache. Psychiatric: Hallucination.
Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Pruritus, rash, urticaria.
🧓 Geriatric Use ▾
Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response 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.
The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.
🆘 Overdosage ▾
OVERDOSAGE The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.
ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine.
However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.
Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine’s clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10 mg are available as 9/32", Orange round biconvex film-coated tablets, debossed “Є” above “159” on one side and plain on the other side, packaged in bottles of 100’s, 500’s and 1000’s. Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side, packaged in bottles of 100’s, 500’s and 1000’s. Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged in bottles of 100’s, 500’s and 1000’s.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev. 01-2023-00 MF159REV01/23 OE1518
📋 Description ▾
DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 CIN 2 O 2 ·2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).
Structural Formula