Hydroxyzine Pamoate 50 mg Capsule, 8-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antihistamine class.
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🏭 Manufacturer & labeler
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🩺 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.
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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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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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 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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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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.
9 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
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💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1145 | $0.92 / 8 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Pamoate 50 mg 00115-1804-01 | Amneal | 100 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine pamoate 50 mg 00185-0676-01 | Sandoz | 100 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine Pamoate 50 mg 00555-0302-02 | Teva | 100 capsules | $0.082 | AB | Availability likely | — |
| hydroxyzine pamoate 50 mg 14539-0675-01 | Heritage | 100 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine Pamoate 50 mg 50268-0399-50 | AvPAK | 50 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine Pamoate 50 mg 60687-0707-01 | American | 100 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine pamoate 50 mg 62135-0817-12 | Chartwell | 120 capsules | $0.082 | AB | Availability likely | — |
| Hydroxyzine Pamoate 50 mg 00615-8420-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 50090-5933-01 | A-S | 20 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 50090-7540-00 | A-S | 12 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 51407-0002-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 50 mg 51655-0252-52 | Northwind | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 66267-0556-90 | NuCare | 90 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 67046-0831-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 68071-3583-09 | NuCare | 90 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 68788-8789-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 70518-3232-00 | REMEDYREPACK | 60 capsules | — | AB | Discontinued | — |
| hydroxyzine pamoate 50 mg 70518-4463-00 | REMEDYREPACK | 21 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 71335-1265-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 50 mgthis 71335-1923-04 | Bryant | 8 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 71335-2076-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 50 mg 72189-0315-90 | DirectRx | 90 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 50 mg 72189-0480-30 | Direct_Rx | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine Pamoate 50 mg 76420-0921-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| hydroxyzine pamoate 50 mg 82868-0046-30 | Northwind | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 87441-0041-01 | Unit | 30 capsules | — | AB | FDA listed | — |
| Hydroxyzine pamoate 50 mg 87441-0042-01 | Unit | 500 capsules | — | AB | FDA listed | — |
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1923-01 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-1) | 2022-01-20 | Active |
| 71335-1923-02 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-2) | 2022-02-14 | Active |
| 71335-1923-03 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-3) | 2022-01-11 | Active |
| 71335-1923-04 You're viewing this | 8 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-4) | 2022-02-14 | Active |
| 71335-1923-05 | 20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-5) | 2022-02-14 | Active |
| 71335-1923-06 | 42 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-6) | 2022-02-14 | Active |
You're viewing the smallest of 6 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1923-04?
What is the difference between NDC 71335-1923-04 and NDC 71335-1923-05?
What NDC number is used to bill for this package of Hydroxyzine Pamoate 50 mg Capsule?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS 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 premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol ® ) 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 For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 mg to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg 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: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient's response to therapy.
⛔ Contraindications ▾
CONTRAINDICATIONS 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 in patients with a prolonged QT interval. Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication. Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.
⚠️ 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 pamoate are usually mild and transitory in nature. Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post-marketing reports. Anticholinergic: Dry mouth.
Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has 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 post-marketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE The most common manifestation of overdosage of hydroxyzine pamoate 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 vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action ) . Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects. 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 pamoate is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine pamoate 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 pamoate's clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) 50 mg capsules: Dark green opaque cap/white opaque body filled with yellow powder and imprinted in black “IX” on the capsule cap and “658” on the capsule body. NDC: 71335-1923-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-1923-2: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-1923-3: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-1923-4: 8 Tablets in a BOTTLE, PLASTIC NDC: 71335-1923-5: 20 Tablets in a BOTTLE, PLASTIC NDC: 71335-1923-6: 42 Tablets in a BOTTLE, PLASTIC Store below 30°C (86°F) [see USP].
Dispense in a tight, light resistant container as defined in USP/NF. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Hydroxyzine pamoate, USP is a light yellow, practically odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1’-methylene bis (2 hydroxy-3-naphthalene carboxylic acid) and can be structurally represented as follows: Chemical Formula: C 21 H 27 ClN 2 O 2 •C 23 H 16 O 6 Molecular Weight: 763.29 Each capsule, for oral administration, contains hydroxyzine pamoate, USP equivalent to 25 mg or 50 mg of hydroxyzine hydrochloride.
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. The imprinting ink on the capsules contains synthetic black iron oxide.