fexofenadine hcl

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133521651
30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1)
ndc11
7133521652
10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2)
ndc11
7133521653
60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3)
ndc11
7133521654
90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4)
ndc11
7133521655
14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5)
ndc11
7133521656
20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6)
ndc11
7133521657
12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)

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": "71335-2165_04a27808-de0a-4100-9aff-3168e4fd231e",
  "productndc": "71335-2165",
  "dosage_form": "TABLET, FILM COATED",
  "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": "20210826",
  "active_numerator_strength": "60"
}

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