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United States · US · US:71399-8042_8ac3ac9a-206b-446a-87c9-bda3b8441cd4

Fexofenadine HCL

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerAkron Pharma Inc.
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7139980421
    100 TABLET in 1 BOTTLE (71399-8042-1)
  • ndc11
    7139980423
    30 TABLET in 1 BOTTLE (71399-8042-3)

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A204507
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": "71399-8042_8ac3ac9a-206b-446a-87c9-bda3b8441cd4",
  "productndc": "71399-8042",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204507",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Sep 16, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Sep 16, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Sep 16, 2015"
      }
    ],
    "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": "ANDA204507",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCL",
  "start_marketing_date": "20200909",
  "active_numerator_strength": "180"
}

Related drugs

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