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United States · US · US:0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4
Fexofenadine Hydrochloride
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110904705040500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40)
- ndc110904705060100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)
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": "0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4",
"productndc": "0904-7050",
"dosage_form": "TABLET",
"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 Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204507",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCl",
"start_marketing_date": "20191129",
"active_numerator_strength": "180"
}Related drugs
Other records sharing ATC code R06AX26.
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