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United States · US · US:62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01

Fexofenadine Hydrochloride

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6220776549
    1000 TABLET in 1 BOTTLE (62207-765-49)
  • ndc11
    6220776551
    1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE
  • ndc11
    6220776560
    8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK
  • ndc11
    6220776588
    5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A211075
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": "62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01",
  "productndc": "62207-765",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2019"
      }
    ],
    "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": "ANDA211075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine Hydrochloride",
  "start_marketing_date": "20201218",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code R06AX26.

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