FEXOFENADINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerAMERISOURCE BERGEN

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4612277958
3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4612277961
1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
4612277966
1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A091567

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": "46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985",
  "productndc": "46122-779",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091567",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Feb 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Feb 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Feb 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Feb 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Feb 6, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "006",
        "approval_date": "Feb 6, 2012"
      }
    ],
    "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": "ANDA091567",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FEXOFENADINE HYDROCHLORIDE",
  "start_marketing_date": "20240514",
  "active_numerator_strength": "180"
}

Related drugs

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