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United States · US · US:55111-360_ae8e6303-9bd6-d6de-79d6-d70b7b736c96

Desloratadine

Orange BookUNIISPLATC R06AX27

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeR06AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5511136006
    6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06)
  • ndc11
    5511136031
    5 BLISTER PACK in 1 CARTON (55111-360-31) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078367
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": "55111-360_ae8e6303-9bd6-d6de-79d6-d70b7b736c96",
  "productndc": "55111-360",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "078367",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jul 12, 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": "ANDA078367",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desloratadine",
  "start_marketing_date": "20130111",
  "active_numerator_strength": "5"
}

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