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United States · US · US:78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f

CLARINEX-D 12 HOUR

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820612001
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)

Annotations

UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
N021313
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": {
    "1af66b7a-4ab8-40d8-abdd-22d3310228a8": {
      "match": "brand_token",
      "title": "CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [ORGANON LLC]",
      "spl_version": "6",
      "published_date": "2025-11-17"
    }
  },
  "productid": "78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f",
  "productndc": "78206-120",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021313",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG;120MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESLORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "CLARINEX-D 12 HOUR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021313",
  "marketing_category": "NDA",
  "nonproprietary_name": "desloratadine and pseudoephedrine sulfate",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "2.5; 120"
}

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