Fexofenadine HCL

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133512171
30 TABLET in 1 BOTTLE (71335-1217-1)
ndc11
7133512172
15 TABLET in 1 BOTTLE (71335-1217-2)
ndc11
7133512173
60 TABLET in 1 BOTTLE (71335-1217-3)
ndc11
7133512174
90 TABLET in 1 BOTTLE (71335-1217-4)
ndc11
7133512175
5 TABLET in 1 BOTTLE (71335-1217-5)
ndc11
7133512176
180 TABLET in 1 BOTTLE (71335-1217-6)
ndc11
7133512177
100 TABLET in 1 BOTTLE (71335-1217-7)

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": "71335-1217_7921f011-b1c5-4bf9-977c-dea10b285be0",
  "productndc": "71335-1217",
  "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"
}

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