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United States · US · US:84324-008_5788217f-a09d-407f-a749-d7fed955ea1b

FEXOFENADINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AX26

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

Identification

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

Packs · 1

  • ndc11
    8432400802
    4 TABLET in 1 BLISTER PACK (84324-008-02)

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A210137
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": "84324-008_5788217f-a09d-407f-a749-d7fed955ea1b",
  "productndc": "84324-008",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210137",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "001",
        "approval_date": "Aug 13, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "FEXOFENADINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210137",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FEXOFENADINE HYDROCHLORIDE",
  "start_marketing_date": "20250609",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code R06AX26.

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