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United States · US · US:85786-204_4ef8be57-98e8-20a9-e063-6394a90ab779

Fexofenadine HCl 180 mg

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerFarmacias De Similares TX LLC
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8578620430
    1 BOTTLE, PLASTIC in 1 CARTON (85786-204-30) / 30 TABLET in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A211075
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52d50976-e63a-b3e3-e063-6294a90a6a97": {
      "match": "brand_token",
      "title": "FEXOFENADINE HCL TABLET [YYBA CORP]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "85786-204_4ef8be57-98e8-20a9-e063-6394a90ab779",
  "productndc": "85786-204",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Fexofenadine HCl 180 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCl",
  "start_marketing_date": "20260408",
  "active_numerator_strength": "180"
}

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