Home NDC 73154-120 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213931-001 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 N213931-002 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 N213931-003 XPHOZAH TENAPANOR HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 N213931-001 10272079 2034-04-10 U-381 2023-11-14 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 N213931-001 10940146 2034-04-10 U-381 2023-11-14 N213931-001 12539299 2042-11-26 Drug product 2026-02-11 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 N213931-002 10272079 2034-04-10 U-381 2023-11-14 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 N213931-002 10940146 2034-04-10 U-381 2023-11-14 N213931-002 12539299 2042-11-26 Drug product 2026-02-11 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 N213931-003 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 N213931-003 10272079 2034-04-10 U-3736 2023-11-14 N213931-003 10272079 2034-04-10 U-381 2023-11-14 N213931-003 10940146 2034-04-10 U-3736 2023-11-14 N213931-003 10940146 2034-04-10 U-381 2023-11-14 N213931-003 12539299 2042-11-26 Drug product 2026-02-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213931-001 NP 2026-10-17 N213931-002 NP 2026-10-17 N213931-003 NP 2026-10-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 57 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-002 XPHOZAH EQ 20MG BASE TABLET / ORAL RLD 2023-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213931-003 XPHOZAH EQ 30MG BASE TABLET / ORAL RLD, RS 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213931-001 XPHOZAH EQ 10MG BASE TABLET / ORAL RLD 2023-10-17 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 10 · 366 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-001 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-002 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10272079 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10272079 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10940146 2034-04-10 U-3736 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 10940146 2034-04-10 U-381 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213931-003 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10272079 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10272079 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10940146 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-001 10940146 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 8541448 2033-08-01 Drug substance, Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10272079 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10272079 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10940146 2034-04-10 U-3736 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-002 10940146 2034-04-10 U-381 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213931-003 8969377 2029-12-30 Drug substance, Drug product 2023-11-14 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 90 observed states.
Additional Listing Data#
Finished product Yes
Brand name base XPHOZAH 20 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TENAPANOR HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50605O2ZNS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2669440 Internal RxNorm lookup 2669446 Internal RxNorm lookup 2669448 Internal RxNorm lookup 2669450 Internal RxNorm lookup 2669452 Internal RxNorm lookup 2669454 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73154-120-14 XPHOZAH 20 mg 14 in 1 BOTTLE TABLET, FILM COATED 14 17 73154-120-60 XPHOZAH 20 mg 60 in 1 BOTTLE TABLET, FILM COATED 60 17 73154-120-99 XPHOZAH 20 mg 14 in 1 BOTTLE TABLET, FILM COATED 14 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73154-120 XPHOZAH 10 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 20 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 30 MG (TENAPANOR) TABLET, FILM COATED [ARDELYX, INC.] 16 Current NDC, 3 package rows 20250502_c57e279c-0f1b-4238-81b7-4e0dc0cc60c5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73154-120-14 73154012014 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-14) 2023-10-17 No No Current 73154-120-60 73154012060 60 TABLET, FILM COATED in 1 BOTTLE (73154-120-60) 2023-10-17 No No Current 73154-120-99 73154012099 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-99) 2023-10-17 Yes No Current