Home NDC 64764-677 ULORIC
Product NDC 64764-677
11-digit product format 647640677
Labeler code 64764
Product ID 64764-677_16c36a5a-2f72-4df7-aa6f-1ca27a39404f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name febuxostat
Dosage form TABLET
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA021856
Marketing category NDA
Marketing start 2009-02-13
Substance FEBUXOSTAT
Active strength 80 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase 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 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# Additional Listing Data#
Finished product Yes
Brand name base ULORIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEBUXOSTAT 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 101V0R1N2E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834235 Internal RxNorm lookup 834239 Internal RxNorm lookup 834241 Internal RxNorm lookup 834243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded febuxostat ACTIVE INGREDIENT 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 febuxostat ACTIVE MOIETY 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 8 febuxostat ACTIVE INGREDIENT 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 febuxostat ACTIVE MOIETY 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ULORIC (FEBUXOSTAT) TABLET [CARDINAL HEALTH] 3 febuxostat ACTIVE INGREDIENT 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 febuxostat ACTIVE MOIETY 101V0R1N2E ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-677 ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 16 Current NDC, Legacy NDC, 5 package rows 20230502_54de10ef-fe5f-4930-b91d-6bbb04c664bd.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 ULORIC FEBUXOSTAT Takeda Pharmaceuticals America, Inc. 54de10ef-fe5f-4930-b91d-6bbb04c664bd 2025-12-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021856 application number: NDA021856 ndc (product): 64764-677
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 64764-677-11 64764067711 10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2009-02-13 0000-00-00 No No Current 64764-677-13 64764067713 100 TABLET in 1 BOTTLE (64764-677-13) 100 tablet 2009-02-13 0000-00-00 No No Current 64764-677-19 64764067719 1000 TABLET in 1 BOTTLE (64764-677-19) 1000 tablet 2009-02-13 0000-00-00 No No Current 64764-677-30 64764067730 30 TABLET in 1 BOTTLE (64764-677-30) 30 tablet 2009-02-13 0000-00-00 No No Current