CETIRIZINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerIndoco Remedies Limited

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1444515201
1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
1444515203
1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE
ndc11
1444515205
1 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE
ndc11
1444515230
1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
1444515290
1 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A218895

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "14445-152_c1a05a6d-3db7-446f-927b-787a062ad1ae",
  "productndc": "14445-152",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218895",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2024"
      }
    ],
    "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": "ANDA218895",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "start_marketing_date": "20241004",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AE.

Access this data programmatically

Query CETIRIZINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs