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United States· US:62207-764_2432f862-6d80-666d-e063-6294a90acf74

Cetirizine hydrochloride

A piperazine derivatives product containing cetirizine hydrochloride, registered in United States by Granules India Ltd.

ATC R06AEOrange BookUS 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…normalisedCetirizine hydrochlorideATCR06AEREGISTER NO.US:62207-764_2432f862…PACKS LISTED3CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about cetirizine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Cetirizine hydrochloride
Manufacturer
Granules India Ltd
Country
United States (US)
ATC code
R06AE
ATC class
Piperazine derivatives
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 3

  • ndc11
    6220776449
    1000 TABLET, COATED in 1 BOTTLE (62207-764-49)
  • ndc11
    6220776455
    14 TABLET, COATED in 1 BOTTLE (62207-764-55)
  • ndc11
    6220776473
    13 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Cetirizine hydrochloride in 16 other countries

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

All cetirizine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Cetiristad, Cetirizin Actavis
  • Belgium · Cetirizin Ab, Cetirizine Eg
  • Bulgaria · Алертесин, Зиртек
  • Cyprus · Agelmin, Temelin
  • Czechia · Allcerin, Analergin
  • Germany · Cetidex, Cetirizin 1 A Pharma
  • Denmark · Alnok, Benaday
  • Estonia · Aceterin, Aceterin Express
  • Spain · Alercina, Alerlisin
  • Finland · Cetimax, Cetirizin Ratiopharm
  • France · Alairgix Allergie, Cetirizine Almus
  • United Kingdom (Northern Ireland) · Allacan, Allergy And Hayfever Relief
  • Greece · Agelmin, Cetirgen
  • Croatia · Letizen, Letizen S
  • Hungary · Cetimax, Cetirizin 1 A Pharma
  • Ireland · Anti-Hist Allergy, Cetirelief Allergy
  • Iceland · Cetirizin Stada, Histasin
  • Italy · Axeramis, Cerchio
  • Lithuania · Aceterin, Aceterin Express
  • Luxembourg · Cetirizine Eg, Reactine
  • Latvia · Aceterin, Alyr
  • Malta · Anti-Hist Allergy, Cetirizine Aurobindo
  • Netherlands · Allergietabletten Cetirizine Dihcl Htp, Cetirizine 2hcl Teva
  • Norway · Cetimax, Cetirizin Norfri
  • Poland · Alermed, Alerzina
  • Portugal · Allertek, Cetirizina Alter Genéricos
  • Romania · Allemax, Celerg
  • Sweden · Cetimax, Cetirizin Abece
  • Slovenia · Cetirizin Pharmasan, Cetixin
  • Slovakia · Alerid, Cetirizin Dr.Max

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/e7d9326e-486c-479a-8b8e-6443e6b44f3c
GET /v1/drugs/e7d9326e-486c-479a-8b8e-6443e6b44f3c?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.

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "817d07cf-5e31-421f-9e95-943bae01f5b0": {
      "match": "brand_token",
      "title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "62207-764_2432f862-6d80-666d-e063-6294a90acf74",
  "productndc": "62207-764",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "209274",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine hydrochloride",
  "start_marketing_date": "20180528",
  "active_numerator_strength": "10"
}
API referenceMCP serverPlans

See everything about cetirizine hydrochloride.

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.

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