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Hydroxyzine Hydrochloride 10 mg Tablet, Film Coated, 100-count — NDC 10702-0010-01 package photo

Hydroxyzine Hydrochloride 10 mg Tablet, Film Coated, 100-count

by KVK-Tech, Inc. · 100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01)
NDC 10702-0010-01
🏷️ FDA NDC (as labeled) 10702-010-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0286 NADAC Per package$2.86 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1710/unit · Part D plans $0.1378/unit — full pricing hub ↓
Also comes in: 500 tablets 10702-0010-50 1000 tablets 10702-0010-10
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

⚠️
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jun 2, 2026 — Presence of foreign substance (ANI Pharmaceuticals, Inc.) · FDA recall D-0619-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 10702-010-01
Product NDC 10702-010
11-digit billing NDC 10702001001
NCPDP billing unit EA — each (per item)
RxCUI 995218, 995258, 995281
UNII 76755771U3
UPC 0310702012103
Application # ANDA040786
SPL Set ID adc4cb73-77c6-48ff-aaf2-b3568d53de1f
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 2012-07-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance HYDROXYZINE DIHYDROCHLORIDE
GPI-14 57200040100305
GPI class hydrOXYzine HCl
GCN Seq No 003726
GCN 13941
HICL code 001608
Ingredient (HICL) Hydroxyzine Hcl
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 HCL 10 MG TABLET
FDB brand name Hydroxyzine Hcl
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 10702-010-01 — 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 → 10702-0010-01. 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

LabelerKVK-Tech, Inc.
Application holderKVK TECH INC
FDA applicationANDA040786 (ANDA)
Labeler code10702
First marketedJul 2012
Product typeHuman Prescription Drug
Portfolio58 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 HCL 10 MG TABLET Ingredient Hydroxyzine Hcl
📖 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 white
ShapeRound
ImprintK;12
Size9 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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 9H4L916OBU
    Hypromellose 2208 is a plant-derived cellulose that thickens and forms protective coats. It's used in medications as a binder to hold ingredients together and as a coating to control how fast the medicine dissolves.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.029 $2.86 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1710 $17.10 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1378 $13.78 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.044 $0.029
▼ Down 24% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Hydrochloride 10 mg 00093-5060-01 Teva 100 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mgthis 10702-0010-01 KVK-Tech, 100 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 16571-0113-01 Rising 100 tablets $0.029 AB Availability likely —
HydrOXYzine Hydrochloride 10 mg 16714-0081-10 Northstar 100 tablets $0.029 AB Availability likely —
Hydroxyzine hydrochloride 10 mg 23155-0500-01 Heritage 100 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 24658-0781-05 PURACAP 500 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 42806-0159-01 Epic 100 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 59651-0499-01 Aurobindo 100 tablets $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 60687-0664-01 American 1 tablet $0.029 AB Availability likely —
Hydroxyzine Hydrochloride 10 mg 62135-0573-05 Chartwell 500 tablets $0.029 AB Availability likely —
Hydroxyzine hydrochloride 10 mg 00615-8563-39 NCS 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 10135-0810-01 Marlex 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 11534-0204-01 Sunrise 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 31722-0500-01 Camber 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 43063-0943-30 PD-Rx 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 43063-0960-01 PD-Rx 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 50090-4117-00 A-S 30 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 10 mg 50090-6682-00 A-S 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 51407-0969-10 Golden 1000 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 51655-0076-52 Northwind 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 60760-0285-20 St 20 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 62135-0545-05 Chartwell 500 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 63629-8738-01 Bryant 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 65162-0575-10 Amneal 100 tablets — — FDA listed —
Hydroxyzine hydrochloride 10 mg 68071-3980-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 68071-4499-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 68788-8716-03 Preferred 30 tablets — — FDA listed —
Hydroxyzine Hydrochloride 10 mg 68788-8872-03 Preferred 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 70518-2807-00 REMEDYREPACK 30 tablets — AB FDA listed —
HydrOXYzine Hydrochloride 10 mg 70518-4360-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 71205-0541-15 Proficient 15 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 71335-0268-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 71335-0961-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 71335-1121-01 Bryant 30 tablets — — FDA listed —
Hydroxyzine Hydrochloride 10 mg 71335-2636-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 71335-3034-01 Bryant 500 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 71335-3088-01 Bryant 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 72162-1332-03 Bryant 30 tablets — — FDA listed —
Hydroxyzine Hydrochloride 10 mg 72162-2511-01 Bryant 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 72189-0333-30 Direct 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 72789-0271-30 PD-Rx 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 10 mg 76420-0881-01 Asclemed 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 10 mg 82804-0288-30 Proficient 30 tablets — 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

🏛️
2012
On the market since
Jul 2012
📍
2026
Currently FDA-listed
14 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 10702-0010-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.8K
Units reimbursed last 4 qtrs
320K
Gross reimbursed last 4 qtrs
$54.7K
Avg / prescription
$9.49
Avg / unit
$0.1710
Latest quarter Q1 2026
1.4KRx
Medicaid pays / ea
$0.1710
gross reimbursed
vs
NADAC / ea
$0.0286
acquisition cost
=
Spread
+$0.1424
+498% 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 ⓘ
42% FFS 58% MCO
Fee-for-service · 2,442 Rx Managed care · 3,326 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 11,259 units · 144 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,025 units · 17.9 per 100k residents MN Wisconsin: 14,548 units · 246 per 100k residents WI Michigan: 24,113 units · 240 per 100k residents MI New York: 39,752 units · 203 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,585 units · 61.1 per 100k residents OR Nevada: 1,980 units · 62.0 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 13,019 units · 406 per 100k residents IA Illinois: 6,091 units · 48.5 per 100k residents IL Indiana: 3,065 units · 44.7 per 100k residents IN Ohio: 20,099 units · 171 per 100k residents OH Pennsylvania: 18,281 units · 141 per 100k residents PA New Jersey: 13,322 units · 143 per 100k residents NJ Massachusetts: 6,150 units · 87.8 per 100k residents MA California: 39,999 units · 103 per 100k residents CA Utah: 3,834 units · 112 per 100k residents UT Colorado: no data reported CO Nebraska: 4,638 units · 234 per 100k residents NE Missouri: 11,128 units · 180 per 100k residents MO Kentucky: 5,661 units · 125 per 100k residents KY West Virginia: 855 units · 48.3 per 100k residents WV Virginia: 540 units · 6.2 per 100k residents VA Maryland: 7,986 units · 129 per 100k residents MD Connecticut: 5,223 units · 144 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,520 units · 119 per 100k residents NM Kansas: 5,839 units · 199 per 100k residents KS Arkansas: no data reported AR Tennessee: 7,710 units · 108 per 100k residents TN North Carolina: 17,088 units · 158 per 100k residents NC South Carolina: 4,037 units · 75.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 6,084 units · 133 per 100k residents LA Mississippi: 576 units · 19.6 per 100k residents MS Alabama: no data reported AL Georgia: 7,187 units · 65.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 6,990 units · 22.9 per 100k residents TX Florida: 6,094 units · 27.0 per 100k residents FL
Units reimbursed · per 100k residents
6.2406
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 Iowa 406 /100k
2 Wisconsin 246 /100k
3 Michigan 240 /100k
4 Nebraska 234 /100k
5 New York 203 /100k
6 Kansas 199 /100k
7 Missouri 180 /100k
8 Ohio 171 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page10702-0010-01 5,768 Rx · $54,739
500 tablets10702-0010-50 2,177 Rx · $24,345
1000 tablets10702-0010-10 No Medicaid data
Drug total (last 4 qtrs): 7,945 Rx · 442,662 units · $79,084 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
10702-0010-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01) $0.0286 / ea $2.86 2012-07-24 Active
10702-0010-10 1000 TABLET, FILM COATED in 1 BOTTLE (10702-010-10) — — 2012-07-24 Active
10702-0010-50 500 TABLET, FILM COATED in 1 BOTTLE (10702-010-50) $0.0286 / ea $14.28 2012-07-24 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0286 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 73% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 10702-0010-01?
NDC 10702-0010-01 is a 100-count package — 100 tablet, film coated in 1 bottle.
What is the difference between NDC 10702-0010-01 and NDC 10702-0010-50?
Both are Hydroxyzine Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. NDC 10702-0010-01 is the 100-count package, while NDC 10702-0010-50 is the 500 tablets package.
What NDC number is used to bill for this package of Hydroxyzine Hydrochloride 10 mg Tablet, Film Coated?
Bill NDC 10702-0010-01 — the 11-digit billing format is 10702001001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 156 words ▾

INDICATIONS AND USAGE 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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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 AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.

⛔ Contraindications 100 words ▾

CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. 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 for patients who have shown a previous hypersensitivity to it.

⚠️ 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 135 words ▾

ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride 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 postmarketing 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 dose. Involuntary motor activity including rare instances of tremor and convulsions have 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 postmarketing 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.

🆘 Overdosage 163 words ▾

OVERDOSAGE The most common manifestation of hydroxyzine overdosage is hypersedation. 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 levarterenol or metaraminol.

Do not use epinephrine as hydroxyzine counteracts its pressor action. 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 130 words ▾

CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine 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’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

📦 How Supplied / Storage and Handling 189 words ▾

HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed "K10" on one side and plain on the other side. Bottle of 100, NDC 10702-010-01 Bottle of 500, NDC 10702-010-50 Bottle of 1000, NDC 10702-010-10 Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed "K11" on one side and plain on the other side. Bottle of 100, NDC 10702-011-01 Bottle of 500, NDC 10702-011-50 Bottle of 1000, NDC 10702-011-10 Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed "K12" on one side and plain on the other side.

Bottle of 100, NDC 10702-012-01 Bottle of 500, NDC 10702-012-50 Bottle of 1000, NDC 10702-012-10 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: KVK-TECH, INC.

110 Terry Drive Newtown, PA 18940 Item ID # 6015/12 11/2018 Manufacturer’s Code: 10702 company logo

📋 Description 74 words ▾

DESCRIPTION Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p -Chloro- α -phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride.

Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol and titanium dioxide. This product complies with USP dissolution test 2. chemical structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10702-0009-01 · KVK-TECH,INC 10702-0011-01 · KVK-Tech, →
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.