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United States · US · US:69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1

Desloratadine

Orange BookUNIISPLATC R06AX27

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

Identification

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

Packs · 2

  • ndc11
    6933919401
    100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01)
  • ndc11
    6933919405
    500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078351
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": {
    "e4db30a5-48e5-4fe3-8793-30b6866f87c1": {
      "match": "brand_token",
      "title": "DESLORATADINE TABLET, FILM COATED [NATCO PHARMA USA LLC]",
      "spl_version": "1",
      "published_date": "2026-04-27"
    }
  },
  "productid": "69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1",
  "productndc": "69339-194",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078351",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 10, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESLORATADINE",
  "proprietary_name": "Desloratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078351",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desloratadine",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "5"
}

Related drugs

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