Home Applications 211801 Application 211801
Type NDA
Sponsor ARDELYX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBSRELA TENAPANOR HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 41 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 2026-09-14 22:38:34 2026-08 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211801-001 IBSRELA EQ 50MG BASE TABLET / ORAL RLD, RS 2019-09-12 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 5 · 182 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211801-001 12539299 2042-11-26 Drug product 2026-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211801-001 12016856 2029-12-30 Drug substance, Drug product 2024-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211801-001 8969377 2029-12-30 Drug substance, Drug product 2019-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211801-001 9408840 2029-12-30 U-2626 2019-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211801-001 9006281 2030-05-02 U-2626 2019-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211801-001 8541448 2033-08-01 Drug substance, Drug product 2019-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211801-001 12539299 2042-11-26 Drug product 2026-02-11 caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73154-050 IBSRELA tenapanor hydrochloride Ardelyx, Inc. NDA Current 73154-050 IBSRELA tenapanor hydrochloride Ardelyx, Inc. NDA Current 73154-050 IBSRELA tenapanor hydrochloride Ardelyx, Inc. NDA Current 73154-050 IBSRELA tenapanor hydrochloride Ardelyx, Inc. NDA Current 73154-050 IBSRELA tenapanor hydrochloride Ardelyx, Inc. NDA Current