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United States · US · US:51824-076_44eb4b3e-e1e7-e47f-e063-6394a90a9b17

CAREALL Cetirizine HCl

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerNew World Imports
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5182407601
    30 TABLET in 1 BOTTLE (51824-076-01)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
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": {
    "ef89a68a-74c1-4c42-8078-b7a208ace0de": {
      "match": "brand_token",
      "title": "CAREALL VITAMIN A AND D (PETROLATUM) OINTMENT [NEW WORLD IMPORTS, INC]",
      "spl_version": "6",
      "published_date": "2026-05-21"
    }
  },
  "productid": "51824-076_44eb4b3e-e1e7-e47f-e063-6394a90a9b17",
  "productndc": "51824-076",
  "dosage_form": "TABLET",
  "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": "CAREALL Cetirizine HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine",
  "start_marketing_date": "20200302",
  "active_numerator_strength": "10"
}

Related drugs

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