Zyrtec Allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerJC World Bell Wholesale Co., Inc

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026997301
20 POUCH in 1 BOX (50269-973-01) / 1 TABLET, FILM COATED in 1 POUCH

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": "50269-973_2a95862d-ede9-4215-e063-6394a90ab4e9",
  "productndc": "50269-973",
  "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": "20180727",
  "active_numerator_strength": "10"
}

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