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United States · US · US:68180-153_816c977e-5e34-42e0-ba3d-c8060f8cfa17

DESLORATADINE

Orange BookUNIISPLATC R06AX27

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

Identification

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

Packs · 2

  • ndc11
    6818015301
    100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01)
  • ndc11
    6818015302
    500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078352
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": "68180-153_816c977e-5e34-42e0-ba3d-c8060f8cfa17",
  "productndc": "68180-153",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078352",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 25, 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": "ANDA078352",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DESLORATADINE",
  "start_marketing_date": "20130225",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AX27.

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