Fexofenadine Hydrochloride

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4580284778
1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A212971

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": "45802-847_e43b561e-d68a-47af-be93-d710f0f77505",
  "productndc": "45802-847",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212971",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Feb 24, 2020"
      }
    ],
    "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": "ANDA212971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fexofenadine hydrochloride",
  "start_marketing_date": "20220107",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code R06AX26.

Access this data programmatically

Query Fexofenadine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs