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United States · US · US:56062-452_239abbb5-c3a5-bcfa-e063-6394a90a66b6

Cetirizine HCl

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPUBLIX SUPER MARKETS INC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5606245286
    1 BOTTLE, PLASTIC in 1 CARTON (56062-452-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N022429
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": "56062-452_239abbb5-c3a5-bcfa-e063-6394a90a66b6",
  "productndc": "56062-452",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "022429",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jul 23, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022429",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20241004",
  "active_numerator_strength": "10"
}

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