Home Applications 021856 Application 021856
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ULORIC FEBUXOSTAT TABLET;ORAL 40MG Yes No 002 ULORIC FEBUXOSTAT TABLET;ORAL 80MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021856-001 ULORIC FEBUXOSTAT 40MG TABLET / ORAL AB RLD 2009-02-13 N021856-002 ULORIC FEBUXOSTAT 80MG TABLET / ORAL AB RLD, RS 2009-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021856-001 8372872 2031-09-08 U-1346 2013-02-26 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 N021856-002 8372872 2031-09-08 U-1346 N021856-002 9107912 2031-09-08 U-1346 2015-09-03
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021856-001 ULORIC 40MG TABLET / ORAL AB RLD 2009-02-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021856-002 ULORIC 80MG TABLET / ORAL AB RLD, RS 2009-02-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 254 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021856-002 8372872 2031-09-08 U-1346 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021856-002 8372872 2031-09-08 U-1346 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-002 8372872 2031-09-08 U-1346 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021856-002 8372872 2031-09-08 U-1346 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-002 8372872 2031-09-08 U-1346 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-002 8372872 2031-09-08 U-1346 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-001 7361676 2024-03-08 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-002 7361676 2024-03-08 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-002 8372872 2031-09-08 U-1346 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-001 7361676 2024-03-08 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-002 7361676 2024-03-08 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-002 8372872 2031-09-08 U-1346 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021856-002 9107912 2031-09-08 U-1346 2015-09-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-001 7361676 2024-03-08 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-001 8372872 2031-09-08 U-1346 2013-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-001 9107912 2031-09-08 U-1346 2015-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021856-002 7361676 2024-03-08 Drug product 5bbf6a4d5a75…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-516 ULORIC febuxostat Rebel Distributors Corp NDA Current 43353-305 ULORIC febuxostat Aphena Pharma Solutions - Tennessee, LLC NDA Current 43353-305 ULORIC febuxostat Aphena Pharma Solutions - Tennessee, LLC NDA Current 55154-5158 ULORIC febuxostat Cardinal Health NDA Current 55154-5158 ULORIC febuxostat Cardinal Health NDA Current 55154-5158 ULORIC febuxostat Cardinal Health NDA Current 55154-5159 ULORIC febuxostat Cardinal Health NDA Current 55154-5159 ULORIC febuxostat Cardinal Health NDA Current 55154-5159 ULORIC febuxostat Cardinal Health NDA Current 64764-677 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-677 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-677 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-677 ULORIC febuxostat Takeda Pharmaceuticals Am NDA Current 64764-918 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-918 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-918 ULORIC febuxostat Takeda Pharmaceuticals America, Inc. NDA Current 64764-918 ULORIC febuxostat Takeda Pharmaceuticals Am NDA Current