FEXOFENADINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerOHM LABORATORIES INC.

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5166099830
1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5166099855
1 BOTTLE in 1 CARTON (51660-998-55) / 150 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": "51660-998_5110b287-1464-50d9-e063-6394a90abe0f",
  "productndc": "51660-998",
  "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": "20220429",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code R06AX26.

Access this data programmatically

Query FEXOFENADINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs