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United States · US · US:84324-001_774a11e0-6c5b-4851-b2bd-453bde344118

Allergy Relief

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 1

  • ndc11
    8432400102
    14 TABLET in 1 BLISTER PACK (84324-001-02)

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": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "84324-001_774a11e0-6c5b-4851-b2bd-453bde344118",
  "productndc": "84324-001",
  "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": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20250609",
  "active_numerator_strength": "10"
}

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