Febuxostat

Product NDC
0378-3926
11-digit product format
003783926
Labeler code
0378
Product ID
0378-3926_3f5600cd-1f2f-410a-8c55-b8363d4fc492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
febuxostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205385
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
0000-00-00
Substance
FEBUXOSTAT
Active strength
80 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-3926DDiscontinued by firm2026-08-17
excluded packagepackage0378-39260378-3926-05DDiscontinued by firm2026-08-17
excluded packagepackage0378-39260378-3926-77DDiscontinued by firm2026-08-17
excluded packagepackage0378-39260378-3926-93DDiscontinued by firm2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-3926-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-3926-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-3926-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-3926-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-3926-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-3926-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-3926-772ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-3926-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-3926-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-3926-77a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-3926-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-3926-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-3926-77cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-3926-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-3926-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-3926-77cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-3926-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-3926-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-3926-77302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-3926-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-3926-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-3926-77ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-3926-93ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-3926-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-3926-770efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-3926-930efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-3926-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-3926-77ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-3926-93ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-3926-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-3926-77367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-3926-93367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-3926-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-3926-77557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-3926-93557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-3926-05557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205385-001FEBUXOSTATFEBUXOSTAT40MGTABLET / ORAL2019-07-01
A205385-002FEBUXOSTATFEBUXOSTAT80MGTABLET / ORAL2019-07-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205385-001FEBUXOSTAT40MGTABLET / ORAL2019-07-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205385-002FEBUXOSTAT80MGTABLET / ORAL2019-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205385-001FEBUXOSTAT40MGTABLET / ORALAB2019-07-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205385-002FEBUXOSTAT80MGTABLET / ORALAB2019-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205385-001FEBUXOSTAT40MGTABLET / ORALAB2019-07-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205385-002FEBUXOSTAT80MGTABLET / ORALAB2019-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205385-001FEBUXOSTAT40MGTABLET / ORALAB2019-07-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205385-002FEBUXOSTAT80MGTABLET / ORALAB2019-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205385-001FEBUXOSTAT40MGTABLET / ORALAB2019-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205385-002FEBUXOSTAT80MGTABLET / ORALAB2019-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205385-001FEBUXOSTAT40MGTABLET / ORALAB2019-07-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205385-002FEBUXOSTAT80MGTABLET / ORALAB2019-07-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205385-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205385-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205385-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205385-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205385-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205385-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205385-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205385-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205385-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205385-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205385-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205385-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205385-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205385-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205385-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205385-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205385-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205385-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205385-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205385-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205385-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A205385-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205385-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A205385-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205385-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A205385-002AB1ea99ee380514…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205385-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205385-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205385-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205385-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205385-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A205385-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205385-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A205385-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205385-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205385-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205385-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A205385-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205385-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A205385-002AB1e64feba35796…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A205385-001PC2019-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205385-002PC2019-12-2874a2ff9319b5…
2019-12-14 00:12 UTC2019-12A205385-001PC2019-12-283f01610625f2…
2019-12-14 00:12 UTC2019-12A205385-002PC2019-12-283f01610625f2…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3926-93EA - Each0378-39261c5931e5-bb42-4f6d-b260-2d19e1eade1e12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3926-930037839269330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3926-93) 2019-07-010000-00-00NoNoCurrent