FEXOFENADINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerCVS PHARMACY, INC

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5131680008
1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE
ndc11
5131680015
1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK
ndc11
5131680030
1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE
ndc11
5131680045
1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE
ndc11
5131680070
1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE
ndc11
5131680090
1 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET 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": "51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cb",
  "productndc": "51316-800",
  "dosage_form": "TABLET",
  "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": "20220920",
  "active_numerator_strength": "180"
}

Related drugs

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