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United States · US · US:78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102

Clarinex

Orange BookUNIISPLATC R06AX27

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeR06AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820611901
    100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
N021165
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FVF865388R",
    "rxcui": "275635",
    "inchikey": "JAUOIFJMECXRGI-UHFFFAOYSA-N",
    "display_name": "DESLORATADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c671342e-69a2-4ca5-abc2-8166ed4240d4": {
      "match": "brand_token",
      "title": "CLARINEX (DESLORATADINE) TABLET, FILM COATED [ORGANON LLC]",
      "spl_version": "6",
      "published_date": "2025-05-28"
    }
  },
  "productid": "78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102",
  "productndc": "78206-119",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021165",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESLORATADINE",
  "proprietary_name": "Clarinex",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021165",
  "marketing_category": "NDA",
  "nonproprietary_name": "Desloratadine",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "5"
}

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