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Hydroxyzine hydrochloride 50 mg Tablet, 100-count — NDC 70518-1265-04 package photo

Hydroxyzine hydrochloride 50 mg Tablet, 100-count

by REMEDYREPACK INC. · 100 POUCH in 1 BOX (70518-1265-4) / 1 TABLET in 1 POUCH (70518-1265-5)
NDC 70518-1265-04
🏷️ FDA NDC (as labeled) 70518-1265-4 billing pads the package segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1378/unit — full pricing hub ↓
Also comes in: 60 tablets 70518-1265-01 100 tablets 70518-1265-02
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) 70518-1265-4
Product NDC 70518-1265
11-digit billing NDC 70518126504
RxCUI 995281
UNII 76755771U3
Application # ANDA204279
SPL Set ID 4c2c4d8e-c3d1-48c7-8f99-ffa159667465
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 2018-06-19
Route ORAL
Dosage form TABLET
Substance HYDROXYZINE DIHYDROCHLORIDE
GCN Seq No 003729
GCN 13944
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 50 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 70518-1265-4 — 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 → 70518-1265-04. 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

LabelerREMEDYREPACK INC.
Application holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA204279 (ANDA)
Labeler code70518
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio1,502 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 50 MG TABLET Ingredient Hydroxyzine Hcl
📗 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
ImprintH;502
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.1378 $13.78 / 100 tablet
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 50 mg 00093-5062-01 Teva 100 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 00904-6618-61 Major 1 tablet $0.058 AB Availability likely —
Hydroxyzine hydrochloride 50 mg 00904-7379-40 Major 500 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 16571-0115-01 Rising 100 tablets $0.058 AB Availability likely —
HydrOXYzine Hydrochloride 50 mg 16714-0083-10 Northstar 100 tablets $0.058 AB Availability likely —
Hydroxyzine hydrochloride 50 mg 23155-0502-01 Heritage 100 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 24658-0783-10 PURACAP 1000 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 42806-0161-01 Epic 100 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 59651-0501-01 Aurobindo 100 tablets $0.058 — Availability likely —
Hydroxyzine Hydrochloride 50 mg 60687-0875-01 American 1 tablet $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 62135-0575-05 Chartwell 500 tablets $0.058 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 10702-0012-01 KVK-Tech, 100 tablets $0.068 AB FDA listed —
Hydroxyzine hydrochloride 50 mg 00615-8564-39 NCS 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 10135-0812-01 Marlex 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 11534-0206-01 Sunrise 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 31722-0502-01 Camber 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 43063-0519-30 PD-Rx 30 tablets — — FDA listed —
Hydroxyzine hydrochloride 50 mg 43063-0779-30 PD-Rx 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 43063-0963-01 PD-Rx 100 tablets — — FDA listed —
HydrOXYzine Hydrochloride 50 mg 50090-2614-00 A-S 100 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 50090-6293-01 A-S 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 51407-0971-10 Golden 1000 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 51655-0119-52 Northwind 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 51655-0467-52 Northwind 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 62135-0547-05 Chartwell 500 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 63187-0354-15 Proficient 15 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 63629-4929-01 Bryant 120 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 65162-0577-10 Amneal 100 tablets — — FDA listed —
HydrOXYzine Hydrochloride 50 mg 67296-2224-01 Redpharm 10 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 68071-5133-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 68071-5291-03 NuCare 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mgthis 70518-1265-04 REMEDYREPACK 100 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 70518-4170-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71205-0083-15 Proficient 15 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71205-0332-15 Proficient 15 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71335-0246-01 Bryant 120 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71335-2185-01 Bryant 120 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71335-2410-01 Bryant 120 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 71335-3036-01 Bryant 1000 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 72162-2167-00 Bryant 1000 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 72162-2513-00 Bryant 1000 tablets — AB FDA listed —
Hydroxyzine HCL 50 mg 72189-0577-60 Direct_rx 60 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 72789-0269-30 PD-Rx 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 72789-0378-30 PD-Rx 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 76420-0883-01 Asclemed 100 tablets — AB FDA listed —
Hydroxyzine HCL 50 mg 80425-0173-01 Advanced 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 80425-0376-01 Advanced 30 tablets — AB FDA listed —
Hydroxyzine Hydrochloride 50 mg 80425-0394-01 Advanced 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 87441-0039-01 Unit 30 tablets — AB FDA listed —
Hydroxyzine hydrochloride 50 mg 70518-0487-01 REMEDYREPACK 90 tablets — AB Discontinued —
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

🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70518-1265-01 60 TABLET in 1 BOTTLE, PLASTIC (70518-1265-1) 2022-10-25 Active
70518-1265-02 100 POUCH in 1 BOX (70518-1265-2) / 1 TABLET in 1 POUCH (70518-1265-3) 2025-10-27 Active
70518-1265-04 You're viewing this 100 POUCH in 1 BOX (70518-1265-4) / 1 TABLET in 1 POUCH (70518-1265-5) 2026-01-05 Active

Pack size FAQ

What quantity is in NDC 70518-1265-04?
NDC 70518-1265-04 is a 100-count package — 100 pouch in 1 box / 1 tablet in 1 pouch.
What is the difference between NDC 70518-1265-04 and NDC 70518-1265-01?
Both are Hydroxyzine hydrochloride 50 mg Tablet — the drug itself is identical. NDC 70518-1265-04 is the 100-count package, while NDC 70518-1265-01 is the 60 tablets package.
What NDC number is used to bill for this package of Hydroxyzine hydrochloride 50 mg Tablet?
Bill NDC 70518-1265-04 — the 11-digit billing format is 70518126504. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 70518-1265-4, 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: 70518-1265-04, written without dashes as 70518126504. 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 70518-1265-04, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (1265) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 REMEDYREPACK INC.. 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 2 other package presentations of this same product, including 60 tablets (70518-1265-01), 100 tablets (70518-1265-02). 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?
REMEDYREPACK INC. 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 155 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 104 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 any component of this medication.

⚠️ 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 137 words ▾

ADVERSE REACTIONS Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports. Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. 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.

In post-marketing experience, the following additional undesirable effects have been reported: Cardiac System: QT prolongation, Torsade de Pointes. Body as a Whole: Allergic reaction. Nervous System : Headache.

Psychiatric : Hallucination. Skin and Appendages : Pruritus, rash, urticaria.

🧓 Geriatric Use 142 words ▾

Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine 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 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 and observed closely.

🆘 Overdosage 174 words ▾

OVERDOSAGE The most common manifestation of hydroxyzine overdosage 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 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 135 words ▾

HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available as follows: 50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows: NDC: 70518-1265-00 NDC: 70518-1265-01 NDC: 70518-1265-02 NDC: 70518-1265-03 NDC: 70518-1265-04 NDC: 70518-1265-05 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 60 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 80 words ▾

DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Molecular Formula: C 21 H 27 ClN 2 O 2 · 2HCl Molecular Weight: 447.83 Hydroxyzine hydrochloride, USP 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, USP.

Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide. stucture

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-1253-01 · REMEDYREPACK 70518-1269-00 · REMEDYREPACK →
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.