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United States · US · US:16714-899_2d00700d-63a2-4a45-b607-028a883fe10a
Fexofenadine HCL
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116714899011 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE
- ndc1116714899021 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A204097
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": "16714-899_2d00700d-63a2-4a45-b607-028a883fe10a",
"productndc": "16714-899",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204097",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG",
"product_no": "001",
"approval_date": "Aug 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG",
"product_no": "002",
"approval_date": "Aug 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "180MG",
"product_no": "003",
"approval_date": "Aug 19, 2016"
}
],
"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": "ANDA204097",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCL",
"start_marketing_date": "20190218",
"active_numerator_strength": "180"
}Related drugs
Other records sharing ATC code R06AX26.
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