Home NDC 70771-1553 febuxostat
Product NDC 70771-1553
11-digit product format 707711553
Labeler code 70771
Product ID 70771-1553_2a9fa82f-de69-4251-8560-5a59d41356b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name febuxostat
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA205443
Marketing category ANDA
Marketing start 2023-03-31
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 A205443-001 FEBUXOSTAT FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 A205443-002 FEBUXOSTAT FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09
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 · 50 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 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205443-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2023-01-09 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205443-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2023-01-09 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 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 · 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1553 FEBUXOSTAT TABLET [ZYDUS LIFESCIENCES LIMITED] 3 Current NDC, 7 package rows 20240821_0629ab39-196e-4198-902a-3c16277ba205.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 · 4 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 70771-1553-0 70771155300 1000 TABLET in 1 BOTTLE (70771-1553-0) 1000 tablet 2023-03-31 No No Current 70771-1553-1 70771155301 100 TABLET in 1 BOTTLE (70771-1553-1) 100 tablet 2023-03-31 No No Current 70771-1553-3 70771155303 30 TABLET in 1 BOTTLE (70771-1553-3) 30 tablet 2023-03-31 No No Current 70771-1553-4 70771155304 10 BLISTER PACK in 1 CARTON (70771-1553-4) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2023-03-31 No No Current 70771-1553-5 70771155305 500 TABLET in 1 BOTTLE (70771-1553-5) 500 tablet 2023-03-31 No No Current 70771-1553-9 70771155309 90 TABLET in 1 BOTTLE (70771-1553-9) 90 tablet 2023-03-31 No No Current