Home NDC 72303-0855 FEBUXOSTAT
Product NDC 72303-0855
11-digit product format 723030855
Labeler code 72303
Product ID 72303-0855_4f1d0d50-8032-d895-e063-6394a90a9bb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name febuxostat
Dosage form TABLET
Route ORAL
Labeler HEC Pharm USA Inc.
Application ANDA213069
Marketing category ANDA
Marketing start 2026-04-10
Substance FEBUXOSTAT
Active strength 40 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213069-001 FEBUXOSTAT FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 A213069-002 FEBUXOSTAT FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 74 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 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213069-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2020-06-02 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213069-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2020-06-02 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FEBUXOSTAT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEBUXOSTAT 40 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 834235 Internal RxNorm lookup 834241 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 72303-0855-1 FEBUXOSTAT 30 in 1 BOTTLE TABLET 30 1
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 Units Marketing start Sample Exclude flag Status 72303-0855-1 72303085501 30 TABLET in 1 BOTTLE (72303-0855-1) 30 tablet 2026-04-10 No No Current