Hydroxyzine Pamoate 50 mg Capsule, 100-count — NDC 0115-1804-01 (Billing 00115-1804-01)
This is a package of 100 capsules of Hydroxyzine Pamoate 50 mg Capsule from Amneal Pharmaceuticals of New York LLC, marketed since Jun 1996 and currently FDA-listed; retail pharmacies pay about $0.0820 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0115-1804-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0115 labeler · 1804 product · 01 package
- Package marketed since
- Jun 15, 1996
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC)
- 0301151803015, 0301151804012
- Medicaid fills, this package
- 212,796 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003732
- GCN: 13953
- HICL (First Databank): 001609
- AHFS class code: 04:04.00.00
- RxCUI (RxNorm): 995253
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Antihistamine class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
- It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
- It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
- Can I drink alcohol or take other sedating medicines with it?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.082 | $8.20 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.1690 | $16.90 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.1145 | $11.45 / 100 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00115-1804-01 You're viewing this Main listing | 100 CAPSULE in 1 BOTTLE, PLASTIC | $0.0820 / ea | $8.20 | 1996-06-15 | — | Active |
| 00115-1804-02 0115-1804-02 | 500 CAPSULE in 1 BOTTLE, PLASTIC | $0.0820 / ea | $40.98 | 1996-06-15 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0820 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 89% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00115-1804-02?
What NDC number is used to bill for this package of Hydroxyzine Pamoate 50 mg Capsule?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Pamoate 50 mgthis 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 mg 71335-1923-01 | Bryant | 30 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?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 Hydroxyzine 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 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 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.
-
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.
-
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.
-
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 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.
-
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.
-
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.
-
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Amneal Pharmaceuticals of New York LLC labeler code 00115
- Acitretin 25 mg Capsule NDC 0115-1753-08
- Cyproheptadine Hydrochloride 4 mg Tablet NDC 0115-1757-01
- Methylphenidate Hydrochloride 5 mg Tablet NDC 0115-1800-01
- Methylphenidate Hydrochloride 10 mg Tablet NDC 0115-1801-01
- Methylphenidate Hydrochloride 20 mg Tablet NDC 0115-1802-01
- Hydroxyzine Pamoate 25 mg Capsule NDC 0115-1803-01
- Colesevelam hydrochloride 3.75 g For Suspension NDC 0115-1864-18
- Rimantadine Hydrochloride 100 mg Tablet, Film Coated NDC 0115-1911-01
- Pyridostigmine Bromide 30 mg Tablet NDC 0115-2134-01
- Terbutaline Sulfate 2.5 mg Tablet NDC 0115-2611-01
- Terbutaline Sulfate 5 mg Tablet NDC 0115-2622-01
- Chloroquine Phosphate 250 mg Tablet NDC 0115-2790-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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) are supplied as follows: 25 mg capsules: Dark green opaque cap/light green opaque body filled with yellow powder and imprinted in black “IX” on the capsule cap and “657” on the capsule body. They are available as follows: Bottles of 100: NDC 0115-1803-01 Bottles of 500: NDC 0115-1803-02 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.
They are available as follows: Bottles of 100: NDC 0115-1804-01 Bottles of 500: NDC 0115-1804-02 Store below 30°C (86°F) [see USP]. Dispense in a tight, light resistant container as defined in USP/NF.
📋 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. 1
⚠️ Precautions ▾
PRECAUTIONS THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine pamoate.
Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased. QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use).
Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias. Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).
Acute Generalized Exanthematous Pustulosis (AGEP): Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity.
If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity. Geriatric Use: A determination has not been made whether controlled clinical studies of hydroxyzine pamoate 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 pamoate 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 pamoate and observed closely.
📚 References ▾
BIBLIOGRAPHY Available on request. Brands listed are the trademarks of their respective owners. Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA OR Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Revised: 03-2026-01
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 25 mg 25 mg 25 mg
PRINCIPAL DISPLAY PANEL - 50 mg 4 12