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United States · US · US:73154-120_4555be24-05c0-4145-80c4-2fbd64d08e52
XPHOZAH 20 mg
Orange BookUNIISPLATC A06AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArdelyx, Inc.
CountryUS (United States)
ATC codeA06AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11731541201414 TABLET, FILM COATED in 1 BOTTLE (73154-120-14)
- ndc11731541206060 TABLET, FILM COATED in 1 BOTTLE (73154-120-60)
- ndc11731541209914 TABLET, FILM COATED in 1 BOTTLE (73154-120-99)
Annotations
UNII (FDA Substance ID)
50605O2ZNS
TENAPANOR HYDROCHLORIDE
RxCUI 2199673
Orange Book
N213931
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "50605O2ZNS",
"rxcui": "2199673",
"inchikey": "VFRAXTZDILCRKY-OWRGXFNZSA-N",
"display_name": "TENAPANOR HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c57e279c-0f1b-4238-81b7-4e0dc0cc60c5": {
"match": "brand_token",
"title": "XPHOZAH 10 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 20 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 30 MG (TENAPANOR) TABLET, FILM COATED [ARDELYX, INC.]",
"spl_version": "17",
"published_date": "2025-07-03"
}
},
"productid": "73154-120_4555be24-05c0-4145-80c4-2fbd64d08e52",
"productndc": "73154-120",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213931",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 17, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Oct 17, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Oct 17, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TENAPANOR HYDROCHLORIDE",
"proprietary_name": "XPHOZAH 20 mg",
"active_ingred_unit": "mg/1",
"application_number": "NDA213931",
"marketing_category": "NDA",
"nonproprietary_name": "Tenapanor",
"start_marketing_date": "20231017",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A06AX08.
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