Back to search
🇺🇸

United States · US · US:69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4

Desloratadine

Orange BookUNIISPLATC R06AX27

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

Identification

ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeR06AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6945236320
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)
  • ndc11
    6945236330
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078357
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": "69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4",
  "productndc": "69452-363",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078357",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 19, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESLORATADINE",
  "proprietary_name": "Desloratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078357",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desloratadine",
  "start_marketing_date": "20231128",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AX27.

Access this data programmatically

Query Desloratadine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.