Home NDC 43547-295 FEBUXOSTAT
Product NDC 43547-295
11-digit product format 435470295
Labeler code 43547
Product ID 43547-295_7125d234-570f-4c51-8e72-8202f4dc299b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name febuxostat
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare US LLC
Application ANDA206266
Marketing category ANDA
Marketing start 2023-08-01
Substance FEBUXOSTAT
Active strength 40 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 A206266-001 FEBUXOSTAT FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 A206266-002 FEBUXOSTAT FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28
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 · 62 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 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206266-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2022-03-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A206266-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2022-03-28 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FEBUXOSTAT
Listing expiration 2026-12-31 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 43547-295-03 FEBUXOSTAT 30 in 1 BOTTLE TABLET 30 7 43547-295-09 FEBUXOSTAT 90 in 1 BOTTLE TABLET 90 7 43547-295-50 FEBUXOSTAT 500 in 1 BOTTLE TABLET 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-295 FEBUXOSTAT TABLET [SOLCO HEALTHCARE US LLC] 7 Current NDC, Legacy NDC, 3 package rows 20250328_4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca.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.
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 43547-295-03 43547029503 30 TABLET in 1 BOTTLE (43547-295-03) 30 tablet 2023-08-01 0000-00-00 No No Current 43547-295-09 43547029509 90 TABLET in 1 BOTTLE (43547-295-09) 90 tablet 2023-08-01 0000-00-00 No No Current 43547-295-50 43547029550 500 TABLET in 1 BOTTLE (43547-295-50) 500 tablet 2023-08-01 0000-00-00 No No Current