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United States · US · US:50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9

Desloratadine

Orange BookUNIISPLATC R06AX27

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR06AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009039750
    90 TABLET in 1 BOTTLE (50090-3975-0)
  • ndc11
    5009039751
    30 TABLET in 1 BOTTLE (50090-3975-1)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078355
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": {
    "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": "50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9",
  "productndc": "50090-3975",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078355",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 19, 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": "ANDA078355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desloratadine",
  "start_marketing_date": "20150612",
  "active_numerator_strength": "5"
}

Related drugs

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