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United States · US · US:63981-147_597ad0d6-abb0-47c1-b9f6-bc37e2968a69

kirkland signature aller tec d

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCostco Wholesale Company
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6398114762
    24 BLISTER PACK in 1 CARTON (63981-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
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": {
    "bf120a48-cc29-4f40-b70d-415868ac9d3e": {
      "match": "brand_token",
      "title": "KIRKLAND SIGNATURE ALLER FLO (FLUTICASONE PROPIONATE) SPRAY, METERED [COSTCO WHOLESALE COMPANY]",
      "spl_version": "8",
      "published_date": "2026-01-14"
    }
  },
  "productid": "63981-147_597ad0d6-abb0-47c1-b9f6-bc37e2968a69",
  "productndc": "63981-147",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210719",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "kirkland signature aller tec d",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA210719",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride",
  "start_marketing_date": "20200330",
  "active_numerator_strength": "5; 120"
}

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