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hydroxyzine pamoate 25 mg Capsule, 120-count — NDC 71335-1714-08 package photo

hydroxyzine pamoate 25 mg Capsule, 120-count

by Bryant Ranch Prepack · 120 CAPSULE in 1 BOTTLE (71335-1714-8)
NDC 71335-1714-08
🏷️ FDA NDC (as labeled) 71335-1714-8 billing pads the package segment with a zero
This package
Contains120-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1145/unit — full pricing hub ↓
Also comes in: 10 capsules 71335-1714-04 15 capsules 71335-1714-05 20 capsules 71335-1714-01 30 capsules 71335-1714-02 42 capsules 71335-1714-09 60 capsules 71335-1714-06 90 capsules 71335-1714-07 100 capsules 71335-1714-03
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) 71335-1714-8
Product NDC 71335-1714
11-digit billing NDC 71335171408
RxCUI 995253
UNII M20215MUFR
Application # ANDA087479
SPL Set ID f74e4b3e-992c-402d-92b8-258fccb42b64
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 1981-12-14
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 71335-1714-8 — a 5-4-1 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 package segment → 71335-1714-08. 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

LabelerBryant Ranch Prepack
Application holderSANDOZ INC
FDA applicationANDA087479 (ANDA)
Labeler code71335
First marketedDec 1981
Product typeHuman Prescription Drug
Portfolio4,433 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 →

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
ShapeCapsule
ImprintE613
Size16 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 U3JF91U133
    Hydroxypropyl cellulose is a plant-derived polymer that acts as a binder, thickener, and film-former in medications. It helps hold tablet ingredients together, control how quickly the drug dissolves, and create protective coatings on pills.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 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 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 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.

17 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1145 $13.74 / 120 capsules
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.

🔁 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 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 mgthis 71335-1714-08 Bryant 120 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

🏛️
1981
On the market since
Dec 1981
📍
2026
Currently FDA-listed
45 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.

📊 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 Marketing startStatus
71335-1714-01 20 CAPSULE in 1 BOTTLE (71335-1714-1) 2021-05-07 Active
71335-1714-02 30 CAPSULE in 1 BOTTLE (71335-1714-2) 2020-10-15 Active
71335-1714-03 100 CAPSULE in 1 BOTTLE (71335-1714-3) 2021-12-29 Active
71335-1714-04 10 CAPSULE in 1 BOTTLE (71335-1714-4) 2021-12-29 Active
71335-1714-05 15 CAPSULE in 1 BOTTLE (71335-1714-5) 2021-12-29 Active
71335-1714-06 60 CAPSULE in 1 BOTTLE (71335-1714-6) 2021-07-14 Active
71335-1714-07 90 CAPSULE in 1 BOTTLE (71335-1714-7) 2021-03-19 Active
71335-1714-08 You're viewing this 120 CAPSULE in 1 BOTTLE (71335-1714-8) 2021-12-29 Active
71335-1714-09 42 CAPSULE in 1 BOTTLE (71335-1714-9) 2021-12-29 Active

You're viewing the largest of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1714-08?
NDC 71335-1714-08 is a 120-count package — 120 capsule in 1 bottle.
What is the difference between NDC 71335-1714-08 and NDC 71335-1714-04?
Both are hydroxyzine pamoate 25 mg Capsule — the drug itself is identical. NDC 71335-1714-08 is the 120-count package, while NDC 71335-1714-04 is the 10 capsules package.
What NDC number is used to bill for this package of hydroxyzine pamoate 25 mg Capsule?
Bill NDC 71335-1714-08 — the 11-digit billing format is 71335171408. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-1714-8, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-1714-08, written without dashes as 71335171408. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-1714-08, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1714) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 10 capsules (71335-1714-04), 15 capsules (71335-1714-05), 20 capsules (71335-1714-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 154 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 132 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

🧓 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 191 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 clinical effects are usually noted within 15 to 30 minutes after oral administration.

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Hydroxyzine Pamoate Capsules, USP, for oral administration, are available as 25 mg (equivalent to 25 mg hydroxyzine hydrochloride) are light green/dark green capsules imprinted “E 613” and supplied as: NDC: 71335-1714-1: 20 Capsules in a BOTTLE NDC: 71335-1714-2: 30 Capsules in a BOTTLE NDC: 71335-1714-3: 100 Capsules in a BOTTLE NDC: 71335-1714-4: 10 Capsules in a BOTTLE NDC: 71335-1714-5: 15 Capsules in a BOTTLE NDC: 71335-1714-6: 60 Capsules in a BOTTLE NDC: 71335-1714-7: 90 Capsules in a BOTTLE NDC: 71335-1714-8: 120 Capsules in a BOTTLE NDC: 71335-1714-9: 42 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 148 words ▾

DESCRIPTION Hydroxyzine pamoate is a light yellow, practically 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) [10246-75-0] and can be structurally represented as follows: C 21 H 27 CIN 2 O 2 •C 23 H 16 O 6 M.W. 763.27 Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg.

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.

Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-1713-01 · Bryant 71335-1715-01 · Bryant →
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.