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Hydroxyzine Pamoate 50 mg Capsule, 500-count

by Amneal Pharmaceuticals of New York LLC · 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02)
NDC 00115-1804-02
🏷️ FDA NDC (as labeled) 0115-1804-02 billing pads the labeler segment with a zero
This package
Contains500-count Cost per ea$0.0820 NADAC Per package$41.00 / 500 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1716/unit · Part D plans $0.1145/unit — full pricing hub ↓
Also comes in: 100 capsules 00115-1804-01
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0115-1804-02
Product NDC 0115-1804
11-digit billing NDC 00115180402
NCPDP billing unit EA — each (per item)
RxCUI 995253, 995278
UNII M20215MUFR
UPC 0301151803015, 0301151804012
Application # ANDA040156
SPL Set ID bc82aaaf-30c7-4afe-a908-d138ea1268ef
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-06-15
Route ORAL
Dosage form CAPSULE
Substance HYDROXYZINE PAMOATE
GCN Seq No 003732
GCN 13953
HICL code 001609
Ingredient (HICL) Hydroxyzine Pamoate
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 HYDROXYZINE PAM 50 MG CAP
FDB brand name Hydroxyzine Pamoate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0115-1804-02 — a 4-4-2 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 labeler segment → 00115-1804-02. 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 Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Diphenylmethane derivatives
How it works Histamine Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals of New York LLC
Application holderIMPAX LABORATORIES INC
FDA applicationANDA040156 (ANDA)
Labeler code00115
First marketedJun 1996
Product typeHuman Prescription Drug
Portfolio228 products on file
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.

🩺 Clinical

Label name HYDROXYZINE PAM 50 MG CAP Ingredient Hydroxyzine Pamoate
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Hydroxyzine 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.082 $41.00 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.1716 $85.80 / 500 capsules
Medicare drug plans payPart D · Q2 2026 $0.1145 $57.25 / 500 capsules
Medicare Part B allowsASP · Q0177 No ASP payment limit on file for Q0177 this quarter.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.106 $0.080
▼ Down 7% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0115-1804-02
11-digit billing NDC00115-1804-02
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ0177
DescriptorHYDROXYZINE PAMOATE, 25 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
Billing units / pkg2 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Pamoate 50 mgthis 00115-1804-02 Amneal 500 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 —
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

🏛️
1996
On the market since
Jun 1996
📍
2026
Currently FDA-listed
30 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.

🗺️ 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 00115-1804-02, 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
25.6K
Units reimbursed last 4 qtrs
1.7M
Gross reimbursed last 4 qtrs
$288.1K
Avg / prescription
$11.27
Avg / unit
$0.1716
Latest quarter Q1 2026
5.9KRx
Medicaid pays / ea
$0.1716
gross reimbursed
vs
NADAC / ea
$0.0820
acquisition cost
=
Spread
+$0.0896
+109% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
22% FFS 78% MCO
Fee-for-service · 5,737 Rx Managed care · 19,823 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 125,244 units · 1,603 per 100k residents WA Idaho: 14,934 units · 760 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,565 units · 43.4 per 100k residents WI Michigan: 74,495 units · 742 per 100k residents MI New York: 9,288 units · 47.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 75,792 units · 1,791 per 100k residents OR Nevada: 29,884 units · 936 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 4,285 units · 134 per 100k residents IA Illinois: 8,800 units · 70.1 per 100k residents IL Indiana: 96,057 units · 1,400 per 100k residents IN Ohio: 475,241 units · 4,033 per 100k residents OH Pennsylvania: 42,689 units · 329 per 100k residents PA New Jersey: 17,928 units · 193 per 100k residents NJ Massachusetts: 2,746 units · 39.2 per 100k residents MA California: 58,484 units · 150 per 100k residents CA Utah: 3,002 units · 87.9 per 100k residents UT Colorado: 129,097 units · 2,196 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 160,609 units · 3,549 per 100k residents KY West Virginia: 38,327 units · 2,165 per 100k residents WV Virginia: 16,348 units · 188 per 100k residents VA Maryland: 41,096 units · 665 per 100k residents MD Connecticut: 4,484 units · 124 per 100k residents CT Rhode Island: no data reported RI Arizona: 43,851 units · 590 per 100k residents AZ New Mexico: 6,411 units · 303 per 100k residents NM Kansas: no data reported KS Arkansas: 5,640 units · 184 per 100k residents AR Tennessee: 29,009 units · 407 per 100k residents TN North Carolina: 3,684 units · 34.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 1,584 units · 39.1 per 100k residents OK Louisiana: 19,993 units · 437 per 100k residents LA Mississippi: 9,639 units · 328 per 100k residents MS Alabama: no data reported AL Georgia: 22,473 units · 204 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 18,126 units · 59.4 per 100k residents TX Florida: 31,945 units · 141 per 100k residents FL
Units reimbursed · per 100k residents
34.04,033
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 Ohio 4,033 /100k
2 Kentucky 3,549 /100k
3 Colorado 2,196 /100k
4 West Virginia 2,165 /100k
5 Oregon 1,791 /100k
6 Washington 1,603 /100k
7 Indiana 1,400 /100k
8 Nevada 936 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules00115-1804-01 212,796 Rx · $2,228,494
500 capsules this page00115-1804-02 25,560 Rx · $288,086
Drug total (last 4 qtrs): 238,356 Rx · 14,863,263 units · $2,516,580 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hydroxyzine Pamoate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydroxyzine Pamoate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.91M
Claims incl. refills
378.4K
Beneficiaries
207.9K
Spend / beneficiary
$18.79
Spend / claim
$10.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydroxyzine pamoate — the ingredient across all brands.

Top reported reactions

Completed Suicide307
Nausea225
Fatigue214
Drug Hypersensitivity200
Pain189
Headache168
Anxiety166

Age at onset

Neonate3
Infant2
Child11
Adolescent22
Adult468
Elderly115

Reporter sex

0 reports

Serious outcomes

Hospitalization1,057
Life-threatening113
Disabling89
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 342 167
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00115-1804-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01) $0.0820 / ea $8.20 1996-06-15 Active
00115-1804-02 You're viewing this 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02) $0.0820 / ea $40.98 1996-06-15 Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0820 NADAC).

This pack accounts for about 11% of this product's recent Medicaid fills; most go to the 100 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00115-1804-02?
NDC 00115-1804-02 is a 500-count package — 500 capsule in 1 bottle, plastic.
What is the difference between NDC 00115-1804-02 and NDC 00115-1804-01?
Both are Hydroxyzine Pamoate 50 mg Capsule — the drug itself is identical. NDC 00115-1804-02 is the 500-count package, while NDC 00115-1804-01 is the 100 capsules package.
What NDC number is used to bill for this package of Hydroxyzine Pamoate 50 mg Capsule?
Bill NDC 00115-1804-02 — the 11-digit billing format is 00115180402. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 155 words ▾

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 165 words ▾

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 102 words ▾

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 29 words ▾

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 148 words ▾

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 192 words ▾

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 132 words ▾

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 120 words ▾

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 125 words ▾

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

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