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hydroxyzine pamoate 25 mg Capsule, 42-count — NDC 71335-1325-09 package photo

hydroxyzine pamoate 25 mg Capsule, 42-count

by Bryant Ranch Prepack · 42 CAPSULE in 1 BOTTLE (71335-1325-9)
NDC 71335-1325-09
🏷️ FDA NDC (as labeled) 71335-1325-9 billing pads the package segment with a zero
This package
Contains42-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1145/unit — full pricing hub ↓
Also comes in: 10 capsules 71335-1325-04 15 capsules 71335-1325-05 20 capsules 71335-1325-01 30 capsules 71335-1325-02 60 capsules 71335-1325-06 90 capsules 71335-1325-07 100 capsules 71335-1325-03 120 capsules 71335-1325-08
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1325-9
Product NDC 71335-1325
11-digit billing NDC 71335132509
RxCUI 995253
UNII M20215MUFR
Application # ANDA201507
SPL Set ID 7996dfa3-7f34-4d20-acaa-7f6fc021fc80
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2022)
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 71335-1325-9 — 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 → 71335-1325-09. 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 holderHERITAGE PHARMA LABS INC
FDA applicationANDA201507 (ANDA)
Labeler code71335
First marketedJun 2013
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
📖 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
ShapeCapsule
ImprintEP;136;EP;136
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 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 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 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 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.

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 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 $4.81 / 42 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 mgthis 71335-1325-09 Bryant 42 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.

📊 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
71335-1325-01 20 CAPSULE in 1 BOTTLE (71335-1325-1) 2019-08-28 Discontinued by firm
71335-1325-02 30 CAPSULE in 1 BOTTLE (71335-1325-2) 2019-08-28 Discontinued by firm
71335-1325-03 100 CAPSULE in 1 BOTTLE (71335-1325-3) 2022-09-19 Discontinued by firm
71335-1325-04 10 CAPSULE in 1 BOTTLE (71335-1325-4) 2022-09-19 Discontinued by firm
71335-1325-05 15 CAPSULE in 1 BOTTLE (71335-1325-5) 2022-09-19 Discontinued by firm
71335-1325-06 60 CAPSULE in 1 BOTTLE (71335-1325-6) 2021-12-22 Discontinued by firm
71335-1325-07 90 CAPSULE in 1 BOTTLE (71335-1325-7) 2021-09-30 Discontinued by firm
71335-1325-08 120 CAPSULE in 1 BOTTLE (71335-1325-8) 2022-09-19 Discontinued by firm
71335-1325-09 You're viewing this 42 CAPSULE in 1 BOTTLE (71335-1325-9) 2022-09-19 Discontinued by firm

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

Pack size FAQ

What quantity is in NDC 71335-1325-09?
NDC 71335-1325-09 is a 42-count package — 42 capsule in 1 bottle.
What is the difference between NDC 71335-1325-09 and NDC 71335-1325-04?
Both are hydroxyzine pamoate 25 mg Capsule — the drug itself is identical. NDC 71335-1325-09 is the 42-count package, while NDC 71335-1325-04 is the 10 capsules package.
What NDC number is used to bill for this package of hydroxyzine pamoate 25 mg Capsule?
Bill NDC 71335-1325-09 — the 11-digit billing format is 71335132509. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 71335-1325-9, 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: 71335-1325-09, written without dashes as 71335132509. 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 71335-1325-09, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1325) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 10 capsules (71335-1325-04), 15 capsules (71335-1325-05), 20 capsules (71335-1325-01). 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 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 132 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: NDC 71335-1325-1: 20 Tablets in a BOTTLE NDC 71335-1325-2: 30 Tablets in a BOTTLE NDC 71335-1325-3: 100 Tablets in a BOTTLE NDC 71335-1325-4: 10 Tablets in a BOTTLE NDC 71335-1325-5: 15 Tablets in a BOTTLE NDC 71335-1325-6: 60 Tablets in a BOTTLE NDC 71335-1325-7: 90 Tablets in a BOTTLE NDC 71335-1325-8: 120 Tablets in a BOTTLE NDC 71335-1325-9: 42 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light resistant containers (USP). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 117 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-1318-01 · Bryant 71335-1329-00 · 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.