Home NDC 71610-386-60 Febuxostat
Product NDC 71610-386
Requested package NDC 71610-386-60
11-digit product format 716100386
Labeler code 71610
Product ID 71610-386_0abfb22b-8115-408a-8ccd-1b38538aa1cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Febuxostat
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA205414
Marketing category ANDA
Marketing start 2019-10-15
Marketing end 0000-00-00
Substance FEBUXOSTAT
Active strength 40 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A205414-001 FEBUXOSTAT FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 A205414-002 FEBUXOSTAT FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15
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 · 80 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 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205414-001 FEBUXOSTAT 40MG TABLET / ORAL AB 2019-10-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205414-002 FEBUXOSTAT 80MG TABLET / ORAL AB 2019-10-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-386-60 Febuxostat 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-386 FEBUXOSTAT TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 1 package rows 20200125_32e8a6f3-2a74-4a2b-8b85-72b5e269dd4b.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Febuxostat FEBUXOSTAT Golden State Medical Supply, Inc. 97a8c7fc-0a66-2ddc-e053-2a95a90ad313 2024-04-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205414 application number: ANDA205414 Febuxostat FEBUXOSTAT Hikma Pharmaceuticals USA Inc 14f1555c-2565-42c7-b3f5-dd5f03fed67a 2023-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205414 application number: ANDA205414 Febuxostat FEBUXOSTAT Aphena Pharma Solutions - Tennessee, LLC bc986925-fd24-4865-997c-ede55c2faffc 2020-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205414 application number: ANDA205414
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 71610-386-60 71610038660 90 TABLET in 1 BOTTLE (71610-386-60) 90 tablet 2020-01-10 0000-00-00 No No Current