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Hydroxyzine Pamoate 25 mg Capsule, 500-count — NDC 00115-1803-02 package photo

Hydroxyzine Pamoate 25 mg Capsule, 500-count

by Amneal Pharmaceuticals of New York LLC · 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-02)
NDC 00115-1803-02
🏷️ FDA NDC (as labeled) 0115-1803-02 billing pads the labeler segment with a zero
This package
Contains500-count Cost per ea$0.0627 NADAC Per package$31.35 / 500 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2047/unit · Part D plans $0.1145/unit — full pricing hub ↓
Also comes in: 100 capsules 00115-1803-01
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) 0115-1803-02
Product NDC 0115-1803
11-digit billing NDC 00115180302
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 1996-07-15
Route ORAL
Dosage form CAPSULE
Substance HYDROXYZINE PAMOATE
GCN Seq No 003731
GCN 13952
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 25 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 0115-1803-02 — 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 → 00115-1803-02. 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 marketedJul 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 25 MG CAP Ingredient Hydroxyzine Pamoate
📖 What it is MedlinePlus · NLM

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 ↗
📗 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.

💊 What it looks like

Color green / white
ShapeCapsule
ImprintIX;658
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 $0.063 $31.35 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.2047 $102.35 / 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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.077 $0.063
▼ Down 12% 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)0115-1803-02
11-digit billing NDC00115-1803-02
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 / pkg1 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 25 mgthis 00115-1803-02 Amneal 500 capsules $0.063 AB Availability likely —
hydroxyzine pamoate 25 mg 00185-0674-01 Sandoz 100 capsules $0.063 AB Availability likely —
Hydroxyzine Pamoate 25 mg 00555-0323-02 Teva 100 capsules $0.063 AB Availability likely —
hydroxyzine pamoate 25 mg 00904-7065-61 Major 100 capsules $0.063 AB Availability likely —
hydroxyzine pamoate 25 mg 14539-0674-01 Heritage 100 capsules $0.063 AB Availability likely —
Hydroxyzine Pamoate 25 mg 50268-0398-50 AvPAK 50 capsules $0.063 AB Availability likely —
Hydroxyzine Pamoate 25 mg 60687-0696-01 American 100 capsules $0.063 AB Availability likely —
Hydroxyzine pamoate 25 mg 62135-0816-12 Chartwell 120 capsules $0.063 AB Availability likely —
Hydroxyzine Pamoate 25 mg 00615-8419-39 NCS 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 43063-0172-01 PD-Rx 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 43063-0406-01 PD-Rx 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 50090-4385-02 A-S 20 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 50090-4579-02 A-S 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51407-0001-01 Golden 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51655-0847-20 Northwind 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 55154-2337-00 Cardinal 10 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 61919-0880-15 Direct_Rx 15 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 63629-8874-01 Bryant 500 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 63629-9612-01 Bryant 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 67046-0281-03 Coupler 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 67046-2086-03 Coupler 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-2255-02 NuCare 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-3736-01 NuCare 100 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 68071-4915-03 NuCare 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68071-4954-03 NuCare 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68788-7767-01 Preferred 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 68788-8119-01 Preferred 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 70518-0209-00 REMEDYREPACK 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 70518-1504-00 REMEDYREPACK 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71205-0087-15 Proficient 15 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71205-0123-15 Proficient 15 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71205-0433-30 Proficient 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71205-0483-30 Proficient 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71205-0558-30 Proficient 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71335-0998-01 Bryant 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-1325-01 Bryant 20 capsules — AB Discontinued —
hydroxyzine pamoate 25 mg 71335-1714-01 Bryant 20 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71335-2187-01 Bryant 20 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-2751-01 Bryant 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71335-3003-01 Bryant 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 71610-0217-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0747-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0773-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 71610-0883-30 Aphena 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 72162-1054-03 Bryant 30 capsules — AB FDA listed —
Hydroxyzine Pamoate 25 mg 72189-0009-30 Direct_Rx 30 capsules — AB Discontinued —
Hydroxyzine Pamoate 25 mg 76420-0920-01 Asclemed 100 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 82982-0032-30 Pharmasource 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 87441-0040-01 Unit 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 51655-0725-52 Northwind 30 capsules — AB FDA listed —
hydroxyzine pamoate 25 mg 87441-0087-01 Unit 30 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
Jul 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 00115-1803-02, 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 – Q4 2025 · 4 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
77.7K
Units reimbursed last 4 qtrs
4.3M
Gross reimbursed last 4 qtrs
$888.4K
Avg / prescription
$11.44
Avg / unit
$0.2047
Latest quarter Q4 2025
19.3KRx
Medicaid pays / ea
$0.2047
gross reimbursed
vs
NADAC / ea
$0.0627
acquisition cost
=
Spread
+$0.1420
+226% 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 ⓘ
25% FFS 75% MCO
Fee-for-service · 19,700 Rx Managed care · 57,955 Rx
State Medicaid map
Alaska: no data reported AK Maine: 18,509 units · 1,327 per 100k residents ME Washington: 120,035 units · 1,537 per 100k residents WA Idaho: 8,543 units · 435 per 100k residents ID Montana: 26,921 units · 2,378 per 100k residents MT North Dakota: 12,936 units · 1,652 per 100k residents ND Minnesota: 72,619 units · 1,266 per 100k residents MN Wisconsin: 22,529 units · 381 per 100k residents WI Michigan: 148,132 units · 1,476 per 100k residents MI New York: 61,203 units · 313 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,359 units · 96.9 per 100k residents NH Oregon: 28,370 units · 670 per 100k residents OR Nevada: 38,727 units · 1,212 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,130 units · 232 per 100k residents SD Iowa: 40,803 units · 1,272 per 100k residents IA Illinois: 69,397 units · 553 per 100k residents IL Indiana: 84,275 units · 1,228 per 100k residents IN Ohio: 686,182 units · 5,823 per 100k residents OH Pennsylvania: 136,174 units · 1,051 per 100k residents PA New Jersey: 27,849 units · 300 per 100k residents NJ Massachusetts: 26,062 units · 372 per 100k residents MA California: 120,826 units · 310 per 100k residents CA Utah: 10,231 units · 299 per 100k residents UT Colorado: 30,904 units · 526 per 100k residents CO Nebraska: 19,290 units · 975 per 100k residents NE Missouri: 204,428 units · 3,299 per 100k residents MO Kentucky: 640,365 units · 14,149 per 100k residents KY West Virginia: 110,023 units · 6,216 per 100k residents WV Virginia: 57,956 units · 665 per 100k residents VA Maryland: 106,953 units · 1,731 per 100k residents MD Connecticut: 17,733 units · 490 per 100k residents CT Rhode Island: 780 units · 71.2 per 100k residents RI Arizona: 48,841 units · 657 per 100k residents AZ New Mexico: 15,871 units · 751 per 100k residents NM Kansas: 11,326 units · 385 per 100k residents KS Arkansas: 111,048 units · 3,621 per 100k residents AR Tennessee: 73,432 units · 1,030 per 100k residents TN North Carolina: 168,873 units · 1,559 per 100k residents NC South Carolina: 30,255 units · 563 per 100k residents SC Delaware: 5,517 units · 535 per 100k residents DE Oklahoma: 90,800 units · 2,240 per 100k residents OK Louisiana: 174,392 units · 3,813 per 100k residents LA Mississippi: 80,298 units · 2,731 per 100k residents MS Alabama: 78,277 units · 1,532 per 100k residents AL Georgia: 88,244 units · 800 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 109,897 units · 360 per 100k residents TX Florida: 234,178 units · 1,036 per 100k residents FL
Units reimbursed · per 100k residents
71.214,149
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 Kentucky 14,149 /100k
2 West Virginia 6,216 /100k
3 Ohio 5,823 /100k
4 Louisiana 3,813 /100k
5 Arkansas 3,621 /100k
6 Missouri 3,299 /100k
7 Mississippi 2,731 /100k
8 Montana 2,378 /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 capsules00115-1803-01 386,026 Rx · $3,745,400
500 capsules this page00115-1803-02 77,655 Rx · $888,356
Drug total (last 4 qtrs): 463,681 Rx · 28,474,994 units · $4,633,756 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
00115-1803-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-01) $0.0627 / ea $6.27 1996-07-15 Active
00115-1803-02 You're viewing this 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-02) $0.0627 / ea $31.35 1996-07-15 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 ($0.0627 NADAC).

This pack accounts for about 17% 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 00115-1803-02?
NDC 00115-1803-02 is a 500-count package — 500 capsule in 1 bottle, plastic.
What is the difference between NDC 00115-1803-02 and NDC 00115-1803-01?
Both are Hydroxyzine Pamoate 25 mg Capsule — the drug itself is identical. NDC 00115-1803-02 is the 500-count package, while NDC 00115-1803-01 is the 100 capsules package.
What NDC number is used to bill for this package of Hydroxyzine Pamoate 25 mg Capsule?
Bill NDC 00115-1803-02 — the 11-digit billing format is 00115180302. 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 ↗
← 00115-1802-01 · Amneal 00115-1804-01 · Amneal →
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.