Fexofenadine Hydrochloride

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerCVS Health Corp.

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6984205215
3 BLISTER PACK in 1 CARTON (69842-052-15) / 5 TABLET in 1 BLISTER PACK
ndc11
6984205218
1 CARTON in 1 CARTON (69842-052-18) / 180 TABLET in 1 CARTON
ndc11
6984205229
3 BLISTER PACK in 1 CARTON (69842-052-29) / 15 TABLET in 1 BLISTER PACK
ndc11
6984205230
1 BOTTLE in 1 CARTON (69842-052-30) / 30 TABLET in 1 BOTTLE
ndc11
6984205245
1 BOTTLE in 1 CARTON (69842-052-45) / 45 TABLET in 1 BOTTLE
ndc11
6984205270
1 BOTTLE in 1 CARTON (69842-052-70) / 70 TABLET in 1 BOTTLE
ndc11
6984205290
1 BOTTLE in 1 CARTON (69842-052-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A076502

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": "69842-052_d9904925-6db2-afaf-c11b-8bbf25249c49",
  "productndc": "69842-052",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076502",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "007",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "008",
        "approval_date": "Apr 12, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "009",
        "approval_date": "Apr 12, 2011"
      }
    ],
    "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": "ANDA076502",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine hydrochloride",
  "start_marketing_date": "20110401",
  "active_numerator_strength": "180"
}

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