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United States · US · US:71610-893_31e71ef2-159c-8273-e063-6294a90aaa08
fexofenadine hcl
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11716108935360 TABLET, FILM COATED in 1 BOTTLE (71610-893-53)
- ndc11716108936090 TABLET, FILM COATED in 1 BOTTLE (71610-893-60)
- ndc117161089370120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70)
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": "71610-893_31e71ef2-159c-8273-e063-6294a90aaa08",
"productndc": "71610-893",
"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": "20240820",
"active_numerator_strength": "180"
}Related drugs
Other records sharing ATC code R06AX26.
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