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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
- ndc1162207765491000 TABLET in 1 BOTTLE (62207-765-49)
- ndc1162207765511 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE
- ndc1162207765608 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK
- ndc1162207765885 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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