HomeNDC LookupIngredientsHydroxyzine Pamoate › 14539-0674-05
hydroxyzine pamoate 25 mg Capsule, 500-count — NDC 14539-0674-05 package photo

hydroxyzine pamoate 25 mg Capsule, 500-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 500 CAPSULE in 1 CONTAINER (14539-674-05)
NDC 14539-0674-05
🏷️ FDA NDC (as labeled) 14539-674-05 billing pads the product 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 $0.1842/unit · Part D plans $0.1145/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 14539-674-05
Product NDC 14539-674
11-digit billing NDC 14539067405
NCPDP billing unit EA — each (per item)
RxCUI 995253, 995278
UNII M20215MUFR
Application # ANDA201507
SPL Set ID 734d32c8-38d3-430f-a2b3-539e03a3687a
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 2013-06-03
Route ORAL
Dosage form CAPSULE
Substance HYDROXYZINE PAMOATE
GPI-14 57200040200105
GPI class 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 14539-674-05 — a 5-3-2 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 product segment → 14539-0674-05. 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

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderHERITAGE PHARMA LABS INC
FDA applicationANDA201507 (ANDA)
Labeler code14539
First marketedJun 2013
Product typeHuman Prescription Drug
Portfolio253 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
📗 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 →
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
ImprintEP;112;EP;112
Size14 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

16 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 DailyMedingredient 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 $0.1842 $92.10 / 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)14539-674-05
11-digit billing NDC14539-0674-05
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product 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 mg 00115-1803-01 Amneal 100 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 mgthis 14539-0674-05 Heritage 500 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

🏛️
2013
On the market since
Jun 2013
📍
2026
Currently FDA-listed
13 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 14539-0674-05, 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
122.7K
Units reimbursed last 4 qtrs
7.6M
Gross reimbursed last 4 qtrs
$1.41M
Avg / prescription
$11.47
Avg / unit
$0.1842
Latest quarter Q4 2025
30.8KRx
Medicaid pays / ea
$0.1842
gross reimbursed
vs
NADAC / ea
$0.0627
acquisition cost
=
Spread
+$0.1215
+194% 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
29% FFS 71% MCO
Fee-for-service · 35,737 Rx Managed care · 86,920 Rx
State Medicaid map
Alaska: 20,258 units · 2,764 per 100k residents AK Maine: 49,855 units · 3,574 per 100k residents ME Washington: no data reported WA Idaho: 39,246 units · 1,998 per 100k residents ID Montana: 21,227 units · 1,875 per 100k residents MT North Dakota: 7,747 units · 989 per 100k residents ND Minnesota: 167,289 units · 2,916 per 100k residents MN Wisconsin: 54,415 units · 921 per 100k residents WI Michigan: 369,200 units · 3,678 per 100k residents MI New York: 105,050 units · 537 per 100k residents NY Vermont: 4,442 units · 687 per 100k residents VT New Hampshire: 27,842 units · 1,986 per 100k residents NH Oregon: 270,046 units · 6,380 per 100k residents OR Nevada: 30,071 units · 941 per 100k residents NV Wyoming: 5,864 units · 1,004 per 100k residents WY South Dakota: 15,768 units · 1,716 per 100k residents SD Iowa: 78,939 units · 2,461 per 100k residents IA Illinois: 82,675 units · 659 per 100k residents IL Indiana: 167,947 units · 2,447 per 100k residents IN Ohio: 715,762 units · 6,074 per 100k residents OH Pennsylvania: 274,847 units · 2,121 per 100k residents PA New Jersey: 58,061 units · 625 per 100k residents NJ Massachusetts: 78,661 units · 1,124 per 100k residents MA California: 545,064 units · 1,399 per 100k residents CA Utah: 11,826 units · 346 per 100k residents UT Colorado: 50,352 units · 857 per 100k residents CO Nebraska: 8,614 units · 435 per 100k residents NE Missouri: 147,937 units · 2,388 per 100k residents MO Kentucky: 457,337 units · 10,105 per 100k residents KY West Virginia: 365,947 units · 20,675 per 100k residents WV Virginia: 322,857 units · 3,704 per 100k residents VA Maryland: no data reported MD Connecticut: 83,424 units · 2,306 per 100k residents CT Rhode Island: 28,621 units · 2,614 per 100k residents RI Arizona: 374,619 units · 5,041 per 100k residents AZ New Mexico: 81,526 units · 3,856 per 100k residents NM Kansas: 34,015 units · 1,157 per 100k residents KS Arkansas: 70,985 units · 2,314 per 100k residents AR Tennessee: 163,521 units · 2,295 per 100k residents TN North Carolina: 254,902 units · 2,353 per 100k residents NC South Carolina: 48,079 units · 895 per 100k residents SC Delaware: 8,215 units · 797 per 100k residents DE Oklahoma: 192,317 units · 4,745 per 100k residents OK Louisiana: 534,270 units · 11,681 per 100k residents LA Mississippi: 95,040 units · 3,233 per 100k residents MS Alabama: 77,805 units · 1,523 per 100k residents AL Georgia: 184,178 units · 1,670 per 100k residents GA D.C.: 2,427 units · 357 per 100k residents DC Hawaii: no data reported HI Texas: 317,947 units · 1,042 per 100k residents TX Florida: 233,087 units · 1,031 per 100k residents FL
Units reimbursed · per 100k residents
34620,675
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 West Virginia 20,675 /100k
2 Louisiana 11,681 /100k
3 Kentucky 10,105 /100k
4 Oregon 6,380 /100k
5 Ohio 6,074 /100k
6 Arizona 5,041 /100k
7 Oklahoma 4,745 /100k
8 New Mexico 3,856 /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.
500 capsules this page14539-0674-05 122,657 Rx · $1,406,693
100 capsules14539-0674-01 114,241 Rx · $1,123,641
Drug total (last 4 qtrs): 236,898 Rx · 15,062,767 units · $2,530,333 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
14539-0674-01 100 CAPSULE in 1 CONTAINER (14539-674-01) $0.0627 / ea $6.27 2019-04-23 Active
14539-0674-05 You're viewing this 500 CAPSULE in 1 CONTAINER (14539-674-05) $0.0627 / ea $31.35 2019-04-23 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).

In Medicaid, this is the most-dispensed pack of this product — about 52% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 14539-0674-05?
NDC 14539-0674-05 is a 500-count package — 500 capsule in 1 container.
What is the difference between NDC 14539-0674-05 and NDC 14539-0674-01?
Both are hydroxyzine pamoate 25 mg Capsule — the drug itself is identical. NDC 14539-0674-05 is the 500-count package, while NDC 14539-0674-01 is the 100 capsules package.
What NDC number is used to bill for this package of hydroxyzine pamoate 25 mg Capsule?
Bill NDC 14539-0674-05 — the 11-digit billing format is 14539067405. 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 153 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.

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 150 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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧓 Geriatric Use 145 words

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.

🆘 Overdosage ~2 min read

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. 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, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 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, 50–100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50–100 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.

🧬 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 121 words

HOW SUPPLIED Hydroxyzine Pamoate Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are available as: 25 mg capsules: Hard gelatin capsules, green opaque cap, green opaque body, cap and body imprinted EP 136 in black ink. They are supplied as follows: Bottles of 100: NDC 14539-674-01 Bottles of 500: NDC 14539-674-05 50 mg capsules: Hard gelatin capsules, white opaque cap, green opaque body, cap and body imprinted EP 112 in black ink. They are supplied as follows: Bottles of 100: NDC 14539-675-01 Bottles of 500: NDC 14539-675-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light resistant containers (USP). Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000293US06 Revised: 06/2025 Image

📋 Description 118 words

DESCRIPTION Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) 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 Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate. structure

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