Fexofenadine HCL

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7120553110
10 TABLET in 1 BOTTLE (71205-531-10)
ndc11
7120553115
15 TABLET in 1 BOTTLE (71205-531-15)
ndc11
7120553120
20 TABLET in 1 BOTTLE (71205-531-20)
ndc11
7120553130
30 TABLET in 1 BOTTLE (71205-531-30)
ndc11
7120553160
60 TABLET in 1 BOTTLE (71205-531-60)
ndc11
7120553190
90 TABLET in 1 BOTTLE (71205-531-90)

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": "71205-531_db8ffe8f-d7f1-48f5-8ed2-9acca4e27884",
  "productndc": "71205-531",
  "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.

Access this data programmatically

Query Fexofenadine HCL 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