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United States · US · US:51316-182_3f168e67-2692-2005-e063-6394a90a747e

CVS Cetirizine Hydrochloride

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 1

  • ndc11
    5131618210
    365 TABLET in 1 BOTTLE (51316-182-10)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077829
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": {
    "e65b3363-71d9-47b6-a044-edac18f9858f": {
      "match": "brand_token",
      "title": "CVS ISOPROPYL RUBBING ALCOHOL PADS (ISOPROPYL ALCOHOL) CLOTH [CVS PHARMACY, INC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "51316-182_3f168e67-2692-2005-e063-6394a90a747e",
  "productndc": "51316-182",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Aug 26, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "CVS Cetirizine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "start_marketing_date": "20251022",
  "active_numerator_strength": "10"
}

Related drugs

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