Home NDC 59922-631 Auryxia
Product NDC 59922-631
11-digit product format 599220631
Labeler code 59922
Product ID 59922-631_79cb63af-94fa-4f49-91d3-543c0058cd4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ferric citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Akebia Therapeutics, Inc.
Application NDA205874
Marketing category NDA
Marketing start 2014-09-17
Substance TETRAFERRIC TRICITRATE DECAHYDRATE
Active strength 210 mg/1
Pharmacologic classes Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 59922-631-92 excluded package package 59922-631-01 excluded package package 59922-631-91
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 N205874-001 AURYXIA FERRIC CITRATE EQ 210MG IRON TABLET / ORAL AB RLD, RS 2014-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205874-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205874-001 8093423 2026-04-21 U-1577 2014-10-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 N205874-001 9387191 2030-07-21 Drug product 2016-08-09
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 2026-02-19 14:30 UTC 2026-02 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205874-001 AURYXIA EQ 210MG IRON TABLET / ORAL RLD, RS 2014-09-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205874-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 526 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 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 7767851 2024-02-18 Drug substance, Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8299298 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8338642 2024-02-18 U-1577 Drug substance, Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8609896 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8754257 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8754258 2024-02-18 Drug product 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8846976 2024-02-18 U-1577 2014-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8901349 2024-02-18 U-1577 2015-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9050316 2024-02-18 U-1577 2015-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9328133 2024-02-18 U-1577 Drug substance, Drug product 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9757416 2024-02-18 U-1577 Drug substance, Drug product 2017-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 8093423 2026-04-21 U-1577 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 10300039 2030-07-21 U-2549 2019-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205874-001 9387191 2030-07-21 Drug product 2016-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 7767851 2024-02-18 Drug substance, Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8299298 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8338642 2024-02-18 U-1577 Drug substance, Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8609896 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8754257 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8754258 2024-02-18 Drug product 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8846976 2024-02-18 U-1577 2014-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 8901349 2024-02-18 U-1577 2015-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9050316 2024-02-18 U-1577 2015-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9328133 2024-02-18 U-1577 Drug substance, Drug product 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205874-001 9757416 2024-02-18 U-1577 Drug substance, Drug product 2017-10-05 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Auryxia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q91187K011 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1594680 Internal RxNorm lookup 1596023 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59922-631-01 Auryxia 200 in 1 BOTTLE TABLET, FILM COATED 200 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59922-631 AURYXIA (FERRIC CITRATE) TABLET, FILM COATED [AKEBIA THERAPEUTICS, INC.] 26 Current NDC, Legacy NDC, 1 package rows 20241222_aadd18e0-3752-11e4-8510-0800200c9a66.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59922-631-01 59922063101 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01) 2014-09-17 0000-00-00 No No Current