Home NDC 73154-050 IBSRELA
Product NDC 73154-050
11-digit product format 731540050
Labeler code 73154
Product ID 73154-050_f077d878-d495-417c-b464-3e7c0c831be7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tenapanor hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ardelyx, Inc.
Application NDA211801
Marketing category NDA
Marketing start 2019-09-12
Substance TENAPANOR HYDROCHLORIDE
Active strength 53.2 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211801-001 IBSRELA TENAPANOR HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 N211801-001 12539299 2042-11-26 Drug product 2026-02-11
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.
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 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD 2019-09-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 170 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 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211801-001 12539299 2042-11-26 Drug product 2026-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211801-001 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 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base IBSRELA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TENAPANOR HYDROCHLORIDE 53.2 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2199679 Internal RxNorm lookup 2199685 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 73154-050-06 IBSRELA 6 in 1 BOTTLE TABLET 6 11 73154-050-60 IBSRELA 60 in 1 BOTTLE TABLET 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73154-050 IBSRELA (TENAPANOR HYDROCHLORIDE) TABLET [ARDELYX, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250323_2102da5f-a1a0-4ac7-a1f6-38698cf7273a.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBSRELA TENAPANOR HYDROCHLORIDE Ardelyx, Inc. 2102da5f-a1a0-4ac7-a1f6-38698cf7273a 2025-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211801 application number: NDA211801 ndc (product): 73154-050
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73154-050-06 73154005006 6 TABLET in 1 BOTTLE (73154-050-06) 6 tablet 2019-09-12 0000-00-00 No No Current 73154-050-60 73154005060 60 TABLET in 1 BOTTLE (73154-050-60) 60 tablet 2019-09-12 0000-00-00 No No Current