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United States · US · US:57483-240_f672cd27-4516-4e54-8c4f-8bbdc22dfabd

Crcle Fexofenadine Hydrochloride

Orange BookUNIIATC R06AX26

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

Identification

ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5748324002
    150 TABLET in 1 CONTAINER (57483-240-02)

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A211075
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",
  "productid": "57483-240_f672cd27-4516-4e54-8c4f-8bbdc22dfabd",
  "productndc": "57483-240",
  "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": "Crcle Fexofenadine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine Hydrochloride",
  "start_marketing_date": "20201218",
  "active_numerator_strength": "180"
}

Related drugs

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