Fexofenadine HCL

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerYYBA Corp

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7358100901
10 TABLET in 1 BOTTLE (73581-009-01)
ndc11
7358100904
40 TABLET in 1 BOTTLE (73581-009-04)
ndc11
7358100910
100 TABLET in 1 BOTTLE (73581-009-10)
ndc11
7358100920
200 TABLET in 1 BOTTLE (73581-009-20)

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A204097

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": "73581-009_52d50de4-dca4-33ff-e063-6394a90a1b09",
  "productndc": "73581-009",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204097",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Aug 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Aug 19, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Fexofenadine HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204097",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCL",
  "start_marketing_date": "20160819",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code R06AX26.

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