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United States · US · US:73154-050_f077d878-d495-417c-b464-3e7c0c831be7
IBSRELA
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 · 2
- ndc1173154050066 TABLET in 1 BOTTLE (73154-050-06)
- ndc11731540506060 TABLET in 1 BOTTLE (73154-050-60)
Annotations
UNII (FDA Substance ID)
50605O2ZNS
TENAPANOR HYDROCHLORIDE
RxCUI 2199673
Orange Book
N211801
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": {
"2102da5f-a1a0-4ac7-a1f6-38698cf7273a": {
"match": "brand_token",
"title": "IBSRELA (TENAPANOR HYDROCHLORIDE) TABLET [ARDELYX, INC.]",
"spl_version": "11",
"published_date": "2025-06-05"
}
},
"productid": "73154-050_f077d878-d495-417c-b464-3e7c0c831be7",
"productndc": "73154-050",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211801",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Sep 12, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TENAPANOR HYDROCHLORIDE",
"proprietary_name": "IBSRELA",
"active_ingred_unit": "mg/1",
"application_number": "NDA211801",
"marketing_category": "NDA",
"nonproprietary_name": "tenapanor hydrochloride",
"start_marketing_date": "20190912",
"active_numerator_strength": "53.2"
}Related drugs
Other records sharing ATC code A06AX08.
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