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United States · US · US:67296-1484_2c62c754-9699-47f7-e063-6294a90a94fe

Zyrtec Allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerRedPharm Drug Inc
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729614843
    30 TABLET, FILM COATED in 1 BOTTLE (67296-1484-3)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N019835
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": {
    "dc613bd5-70fd-1d9b-e053-2995a90a41cd": {
      "match": "brand_token",
      "title": "ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
      "spl_version": "9",
      "published_date": "2026-04-30"
    }
  },
  "productid": "67296-1484_2c62c754-9699-47f7-e063-6294a90a94fe",
  "productndc": "67296-1484",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019835",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "Nov 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Zyrtec Allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019835",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20080101",
  "active_numerator_strength": "10"
}

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