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United States· US:43063-963_415f3642-ef05-3671-e063-6294a90ab7a7

Hydroxyzine Hydrochloride

A hydroxyzine product containing hydroxyzine dihydrochloride, registered in United States by PD-Rx Pharmaceuticals, Inc.. The same ATC class is registered in 15 of our 19 countries.

ATC N05BB01US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedHydroxyzine HydrochlorideATCN05BB01REGISTER NO.US:43063-963_415f3642…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Hydroxyzine is registered in 15 of 19 countries.

Countries holding a registration under ATC N05BB01 (hydroxyzine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose

Hydroxyzine · ATC N05BB01

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of hydroxyzine costs, country by country.

Normalised to the WHO defined daily dose (75 mg), the median price runs from $0.16 in United States to $1.68 in Switzerland — a ×11 gap.

  • United States: $0.16 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Hydroxyzine · price per daily dose (75 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$1.68
  • US United States$0.16 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HYDROXYZINE DIHYDROCHLORIDE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Country
United States (US)
ATC code
N05BB01
ATC class
Hydroxyzine
Defined daily dose
75 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    43063-963-01
  • ndc11
    43063-963-95
  • ndc11
    4306396301
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-01)
  • ndc11
    4306396395
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-95)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

410 interactions on record for hydroxyzine.

Graded by severity as the source publishes them — 46 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Hydroxyzine · interactions on record

410 records

  • 46 severe
  • 199 moderate
  • 5 minor
  • 160 info

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • DolasetronA04AA04severe
  • Potassium chlorideA12BA01severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Hydroxyzine in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All hydroxyzine products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Atarax, Hydroxyzin Bluefish
  • Belgium · Atarax
  • Bulgaria · Атаракс, Неуролакс
  • Cyprus · Atarax
  • Czechia · Atarax
  • Germany · Atarax, Hydroxyzin Bluefish
  • Denmark · Hydroxyzine Bluefish, Hydroxyzine Medical Valley
  • Spain · Atarax, Hidroxizina Bluefish
  • Finland · Atarax, Hydroxyzine Orifarm
  • France · Atarax, Hydroxyzine Arrow
  • United Kingdom (Northern Ireland) · Atarax, Hydroxyzine Hydrochloride 25mg
  • Greece · Atarax, Efidac
  • Hungary · Atarax
  • Ireland · Hydroxyzine Hydrochloride Brillpharma (Ireland)
  • Iceland · Atarax, Hydroxyzine Bluefish
  • Italy · Atarax
  • Luxembourg · Atarax
  • Netherlands · Hydroxyzine-2hcl Ucb Pharma
  • Norway · Atarax, Hydroxyzine Bluefish
  • Poland · Atarax, Comfortin
  • Portugal · Atarax, Fenartix
  • Sweden · Atarax, Hydroxizin Omet Pharma
  • Slovakia · Atarax

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/ea77a4af-284f-4b62-a0cd-de1509ae5ee2
GET /v1/drugs/ea77a4af-284f-4b62-a0cd-de1509ae5ee2?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "50",
  "substance": "HYDROXYZINE DIHYDROCHLORIDE",
  "productndc": "43063-963",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA040788",
  "marketing_category": "ANDA"
}

See everything about hydroxyzine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.