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United States · US · US:71399-8042_8ac3ac9a-206b-446a-87c9-bda3b8441cd4
Fexofenadine HCL
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAkron Pharma Inc.
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117139980421100 TABLET in 1 BOTTLE (71399-8042-1)
- ndc11713998042330 TABLET in 1 BOTTLE (71399-8042-3)
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": "71399-8042_8ac3ac9a-206b-446a-87c9-bda3b8441cd4",
"productndc": "71399-8042",
"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 HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204507",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCL",
"start_marketing_date": "20200909",
"active_numerator_strength": "180"
}Related drugs
Other records sharing ATC code R06AX26.
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