FDA.reportPublic FDA data

XPHOZAH 20 mg

Product NDC
73154-120
11-digit product format
731540120
Labeler code
73154
Product ID
73154-120_4555be24-05c0-4145-80c4-2fbd64d08e52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenapanor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ardelyx, Inc.
Application
NDA213931
Marketing category
NDA
Marketing start
2023-10-17
Substance
TENAPANOR HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA], Sodium-Hydrogen Exchanger 3 Inhibitor [EPC], Sodium-Hydrogen Exchanger 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XPHOZAH 20 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENAPANOR HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50605O2ZNS
Rxcui2669440, 2669446, 2669448, 2669450, 2669452, 2669454

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a66b2652-5c38-4b20-b419-82a424ce326dProduct name120250630
74856dfc-c6dc-46af-81b2-26709a9bdfc7Product name120200224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73154-120-14XPHOZAH 20 mg14 in 1 BOTTLETABLET, FILM COATED1417
73154-120-60XPHOZAH 20 mg60 in 1 BOTTLETABLET, FILM COATED6017
73154-120-99XPHOZAH 20 mg14 in 1 BOTTLETABLET, FILM COATED1417

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73154-120-60EA - Each73154-120fce7e819-9b47-47e9-af85-5edfbb62715912023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73154-120XPHOZAH 10 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 20 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 30 MG (TENAPANOR) TABLET, FILM COATED [ARDELYX, INC.]16Current NDC, 3 package rows20250502_c57e279c-0f1b-4238-81b7-4e0dc0cc60c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2669440tenapanor 10 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669448tenapanor 20 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669452tenapanor 30 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669446XPHOZAH 10 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669450XPHOZAH 20 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669454XPHOZAH 30 MG Oral TabletPSNc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669446tenapanor 10 MG Oral Tablet [Xphozah]SBDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669450tenapanor 20 MG Oral Tablet [Xphozah]SBDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669454tenapanor 30 MG Oral Tablet [Xphozah]SBDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669440tenapanor 10 MG Oral TabletSCDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669448tenapanor 20 MG Oral TabletSCDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669452tenapanor 30 MG Oral TabletSCDc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669440tenapanor 10 MG (as tenapanor hydrochloride 10.6 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669448tenapanor 20 MG (as tenapanor hydrochloride 21.3 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669452tenapanor 30 MG (as tenapanor hydrochloride 31.9 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669446Xphozah 10 MG (as tenapanor hydrochloride 10.6 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669446Xphozah 10 MG Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669450Xphozah 20 MG (as tenapanor hydrochloride 21.3 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669450Xphozah 20 MG Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669454Xphozah 30 MG (as tenapanor hydrochloride 31.9 MG) Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517
2669454Xphozah 30 MG Oral TabletSYc57e279c-0f1b-4238-81b7-4e0dc0cc60c517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73154-120-147315401201414 TABLET, FILM COATED in 1 BOTTLE (73154-120-14) 2023-10-17NoNoCurrent
73154-120-607315401206060 TABLET, FILM COATED in 1 BOTTLE (73154-120-60) 2023-10-17NoNoCurrent
73154-120-997315401209914 TABLET, FILM COATED in 1 BOTTLE (73154-120-99) 2023-10-17YesNoCurrent