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HydrOXYzine Hydrochloride 50 mg Tablet, 500-count — NDC 16714-0083-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HydrOXYzine Hydrochloride 50 mg Tablet, 500-count — NDC 16714-083-11 (Billing 16714-0083-11)

by Northstar RxLLC · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of HydrOXYzine Hydrochloride 50 mg Tablet from Northstar RxLLC, marketed since Nov 2009 and currently FDA-listed; retail pharmacies pay about $0.0558 per tablet (NADAC).

NDC 16714-0083-11
🏷️ FDA NDC (as labeled) 16714-083-11 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0558 NADAC Per package$27.90 / 500 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2039/unit · Part D plans $0.1378/unit — full pricing hub ↓
Product page 16714-0083-10 Also comes in: 100 tablets 16714-083-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16714-083-11
Product NDC 16714-083
11-digit billing NDC 16714008311
NCPDP billing unit EA — each (per item)
RxCUI 995218, 995258, 995281
UNII 76755771U3
UPC 0316714081106, 0316714082103, 0316714083100
Application # ANDA040840
SPL Set ID 8e5fce17-936e-46ea-a969-518c952c2091
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 2009-11-11
Route ORAL
Dosage form TABLET
Substance HYDROXYZINE DIHYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 57200040100315
GPI class hydrOXYzine HCl
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
Quick answers
  • GSN (GCN sequence number): 003729
  • GCN: 13944
  • GPI-14 (Medi-Span): 57200040100315
  • HICL (First Databank): 001608
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 995218
Why two NDCs? The FDA registers this code as 16714-083-11 — 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 → 16714-0083-11. 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.

Clinical

Label name HYDROXYZINE HCL 50 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
  • Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
  • It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
  • It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
  • Can I drink alcohol or take other sedating medicines with it?
📖 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.

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 $0.056 $27.90 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.2039 $101.95 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.1378 $68.90 / 500 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.096 $0.056
▼ Down 40% 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
16714-0083-10 16714-083-10 Main listing 100 TABLET in 1 BOTTLE $0.0558 / ea $5.58 2009-11-11 — Active
16714-0083-11 You're viewing this 500 TABLET in 1 BOTTLE $0.0558 / ea $27.88 2009-11-11 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0558 NADAC).

This pack accounts for about 21% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 16714-0083-10?
Both are HydrOXYzine Hydrochloride 50 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 16714-0083-10 is the 100 tablets package.
What NDC number is used to bill for this package of HydrOXYzine Hydrochloride 50 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyzine Hydrochloride 50 mg 00093-5062-01 Teva 100 tablets $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 00904-6618-61 Major 1 tablet $0.056 AB Discontinued —
Hydroxyzine hydrochloride 50 mg 00904-7379-40 Major 500 tablets $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 16571-0115-01 Rising 100 tablets $0.056 AB Availability likely —
HydrOXYzine Hydrochloride 50 mgthis 16714-0083-11 Northstar 500 tablets $0.056 AB Availability likely —
Hydroxyzine hydrochloride 50 mg 23155-0502-01 Heritage 100 tablets $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 24658-0783-10 PURACAP 1000 tablets $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 59651-0501-01 Aurobindo 100 tablets $0.056 — Availability likely —
Hydroxyzine Hydrochloride 50 mg 60687-0875-01 American 1 tablet $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 62135-0575-05 Chartwell 500 tablets $0.056 AB Availability likely —
Hydroxyzine Hydrochloride 50 mg 42806-0161-01 Epic 100 tablets $0.058 AB Availability likely +5%
Hydroxyzine Hydrochloride 50 mg 10702-0012-01 KVK-Tech, 100 tablets $0.068 AB FDA listed +23%
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 mg 70518-1265-01 REMEDYREPACK 60 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

🏛️
2009
On the market since
Nov 2009
📍
2026
Currently FDA-listed
17 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.

What it looks like

Color White
ShapeRound
ImprintN006
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.

Manufacturer & labeler

LabelerNorthstar RxLLC
Application holderNORTHSTAR HEALTHCARE HOLDINGS LTD
FDA applicationANDA040840 (ANDA)
Labeler code16714
First marketedNov 2009
Product typeHuman Prescription Drug
Portfolio308 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.

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 ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 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 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 128 words ▾

ADVERSE REACTIONS 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: Oral hydrOXYzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed eruptions in postmarketing reports. 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 171 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 incases 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 182 words ▾

HOW SUPPLIED HydrOXYzine Hydrochloride Tablets, USP are supplied as: 10 mg - White, biconvex, circular, coated tablets with '112' debossed on one face and 'N' on the other face. Bottles of 100 tablets NDC 16714-081-10 Bottles of 500 tablets NDC 16714-081-11 25 mg- White, biconvex, circular, coated tablets with 'N004' debossed on one face and plain on the other face. Bottles of 100 tablets NDC 16714-082-10 Bottles of 500 tablets NDC 16714-082-11 Bottles of 1000 tablets NDC 16714-082-12 50 mg- White, biconvex, circular, coated tablets with 'N006' debossed on one face and plain on the other face.

Bottles of 100 tablets NDC 16714-083-10 Bottles of 500 tablets NDC 16714-083-11 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.

Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free Number: 1-800-206-7821 Manufactured by: Piramal Pharma Limited, Plot No. 67-70, Sector-2, Pithampur 454 775, Dist.: Dhar, Madhya Pradesh, INDIA. August 2022

📋 Description 139 words ▾

DESCRIPTION HydrOXYzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy]ethanol dihydrochloride. HydrOXYzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water; soluble in chloroform; slightly soluble in acetone; practically insoluble in ether. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydrOXYzine hydrochloride USP.

Inactive ingredients for 10 mg include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. Inactive ingredients for 25 mg include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. Inactive ingredients for 50 mg include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. hydroxyzine-str

⚠️ Precautions ~2 min read ▾

PRECAUTIONS THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydrOXYzine their dosage should be reduced. QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydrOXYzine.

The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydrOXYzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydrOXYzine. Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased. 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. Acute Generalized Exanthematous Pustulosis (AGEP) HydrOXYzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema.

Inform patients about the signs of AGEP, and discontinue hydrOXYzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydrOXYzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydrOXYzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydrOXYzine, due to the risk of cross-sensitivity.

🍼 Nursing Mothers 28 words ▾

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.

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal Display Panel - HydrOXYzine Hydrochloride Tablets USP, 10 mg - 100's Pack Rx only NDC 16714-081-10 HydrOXYzine Hydrochloride Tablets, USP 10 mg 100 Tablets NORTHSTARx ® Each tablet contains 10 mg of hydrOXYzine hydrochloride,USP. Usual dosage: See package outsert for full prescribing information. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Storage: Store at 20°C to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Product of Italy Manufactured for: Northstar Rx LLC Memphis, TN38141. Manufactured by: Piramal Pharma Limited, Plot No.

67 - 70, Sector - 2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA. Mfg Lic.

No.: 25/10/92 20689715 EM 14793/e Rev. 09/2025 Bar code © 2005 Northstar Healthcare UC. Hydroxyzine-fig1

Principal Display Panel - HydrOXYzine Hydrochloride Tablets USP, 25 mg - 100's Pack Rx only NDC 16714-082-10 HydrOXYzine Hydrochloride Tablets, USP 25 mg 100 Tablets NORTHSTARx ® Each tablet contains 25 mg of hydrOXYzine hydrochloride,USP. Usual dosage: See package outsert for full prescribing information. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Storage: Store at 20°C to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Product of Italy Manufactured for: Northstar Rx LLC Memphis, TN38141. Manufactured by: Piramal Pharma Limited, Plot No.

67 - 70, Sector - 2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA. Mfg Lic.

No.: 25/10/92 20689720 EM 14795/e Rev. 09/2025 Bar Code © 2005 Northstar Healthcare UC. Hydroxyzine-fig2

Principal Display Panel - HydrOXYzine Hydrochloride Tablets USP ,50 mg - 100's Pack Rx only NDC 16714-083-10 HydrOXYzine Hydrochloride Tablets, USP 50 mg 100 Tablets NORTHSTARx ® Each tablet contains 50 mg of hydrOXYzine hydrochloride,USP. Usual dosage: See package outsert for full prescribing information. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Storage: Store at 20°C to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Product of Italy Manufactured for: Northstar Rx LLC Memphis, TN38141. Manufactured by: Piramal Pharma Limited, Plot No.

67 - 70, Sector - 2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA. Mfg Lic.

No.: 25/10/92 20689712 EM 14798/e Rev.09/2025 Bar Code © 2005 Northstar Healthcare UC. Hydroxyzine-fig3

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

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 this package alone, 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
57.4K
Units reimbursed last 4 qtrs
3.5M
Gross reimbursed last 4 qtrs
$719.8K
Avg / prescription
$12.54
Avg / unit
$0.2039
Latest quarter Q1 2026
9.5KRx
Medicaid pays / ea
$0.2039
gross reimbursed
vs
NADAC / ea
$0.0558
acquisition cost
=
Spread
+$0.1481
+265% 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 ⓘ
49% FFS 51% MCO
Fee-for-service · 27,934 Rx Managed care · 29,478 Rx
State Medicaid map
Alaska: 18,618 units · 2,540 per 100k residents AK Maine: 10,957 units · 785 per 100k residents ME Washington: 49,980 units · 640 per 100k residents WA Idaho: 28,786 units · 1,466 per 100k residents ID Montana: 38,015 units · 3,358 per 100k residents MT North Dakota: 3,095 units · 395 per 100k residents ND Minnesota: 110,844 units · 1,932 per 100k residents MN Wisconsin: 114,290 units · 1,934 per 100k residents WI Michigan: 139,650 units · 1,391 per 100k residents MI New York: 425,794 units · 2,176 per 100k residents NY Vermont: 2,872 units · 444 per 100k residents VT New Hampshire: 6,050 units · 432 per 100k residents NH Oregon: 18,839 units · 445 per 100k residents OR Nevada: 9,329 units · 292 per 100k residents NV Wyoming: 1,186 units · 203 per 100k residents WY South Dakota: 1,455 units · 158 per 100k residents SD Iowa: 29,532 units · 921 per 100k residents IA Illinois: 87,900 units · 700 per 100k residents IL Indiana: 89,187 units · 1,300 per 100k residents IN Ohio: 303,759 units · 2,578 per 100k residents OH Pennsylvania: 110,998 units · 856 per 100k residents PA New Jersey: 43,222 units · 465 per 100k residents NJ Massachusetts: 49,188 units · 703 per 100k residents MA California: 328,826 units · 844 per 100k residents CA Utah: 5,841 units · 171 per 100k residents UT Colorado: 79,771 units · 1,357 per 100k residents CO Nebraska: 7,720 units · 390 per 100k residents NE Missouri: 195,176 units · 3,150 per 100k residents MO Kentucky: 128,086 units · 2,830 per 100k residents KY West Virginia: 36,162 units · 2,043 per 100k residents WV Virginia: 21,861 units · 251 per 100k residents VA Maryland: 168,666 units · 2,729 per 100k residents MD Connecticut: 54,645 units · 1,511 per 100k residents CT Rhode Island: 4,543 units · 415 per 100k residents RI Arizona: 132,273 units · 1,780 per 100k residents AZ New Mexico: 28,105 units · 1,329 per 100k residents NM Kansas: 7,496 units · 255 per 100k residents KS Arkansas: 57,327 units · 1,869 per 100k residents AR Tennessee: 24,897 units · 349 per 100k residents TN North Carolina: 25,183 units · 232 per 100k residents NC South Carolina: 5,762 units · 107 per 100k residents SC Delaware: 2,178 units · 211 per 100k residents DE Oklahoma: 31,427 units · 775 per 100k residents OK Louisiana: 37,341 units · 816 per 100k residents LA Mississippi: 830 units · 28.2 per 100k residents MS Alabama: 9,805 units · 192 per 100k residents AL Georgia: 7,240 units · 65.6 per 100k residents GA D.C.: 6,715 units · 989 per 100k residents DC Hawaii: no data reported HI Texas: 390,259 units · 1,279 per 100k residents TX Florida: 38,094 units · 168 per 100k residents FL
Units reimbursed · per 100k residents
28.23,358
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 Montana 3,358 /100k
2 Missouri 3,150 /100k
3 Kentucky 2,830 /100k
4 Maryland 2,729 /100k
5 Ohio 2,578 /100k
6 Alaska 2,540 /100k
7 New York 2,176 /100k
8 West Virginia 2,043 /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 tablets16714-0083-10 215,843 Rx · $2,443,740
500 tablets this page16714-0083-11 57,412 Rx · $719,768
Drug total (last 4 qtrs): 273,255 Rx · 17,676,755 units · $3,163,508 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 16714-0082-10 · Northstar 16714-0087-01 · NorthStar →
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.