Fenoglide

Product NDC
68012-490
Requested package NDC
68012-490-90
11-digit product format
680120490
Labeler code
68012
Product ID
68012-490_ae9a87e8-23dd-492c-907e-51ea9d58eb97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Santarus, Inc.
Application
NDA022118
Marketing category
NDA
Marketing start
2010-11-18
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
40 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68012-49068012-490-90DDiscontinued by firm2026-08-10

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022118-001FENOGLIDEFENOFIBRATE40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2007-08-10
N022118-002FENOGLIDEFENOFIBRATE120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2007-08-10

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022118-001FENOGLIDE40MGTABLET / ORALRLD2007-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022118-002FENOGLIDE120MGTABLET / ORALRLD2007-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022118-001FENOGLIDE40MGTABLET / ORALABRLD2007-08-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N022118-002FENOGLIDE120MGTABLET / ORALABRLD, RS2007-08-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05N022118-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022118-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022118-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022118-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022118-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022118-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022118-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022118-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022118-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022118-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022118-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022118-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022118-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N022118-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022118-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022118-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022118-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022118-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022118-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022118-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022118-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022118-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022118-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N022118-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022118-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N022118-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022118-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N022118-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022118-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022118-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022118-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022118-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022118-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022118-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022118-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022118-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022118-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022118-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022118-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022118-002AB1a67488948f0b…

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00181241252024-10-01U-1234Drug product2012-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00184810782024-10-01U-1416Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00191738472024-10-01Drug product2015-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00176589442024-12-09Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00281241252024-10-01U-1234Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00284810782024-10-01U-1416Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00291738472024-10-01Drug product2015-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022118-00276589442024-12-09Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00181241252024-10-01U-1234Drug product2012-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00184810782024-10-01U-1416Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00191738472024-10-01Drug product2015-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00176589442024-12-09Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00281241252024-10-01U-1234Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00284810782024-10-01U-1416Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00291738472024-10-01Drug product2015-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022118-00276589442024-12-09Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00181241252024-10-01U-1234Drug product2012-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00184810782024-10-01U-1416Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00191738472024-10-01Drug product2015-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00176589442024-12-09Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00281241252024-10-01U-1234Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00284810782024-10-01U-1416Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00291738472024-10-01Drug product2015-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022118-00276589442024-12-09Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00181241252024-10-01U-1234Drug product2012-03-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00184810782024-10-01U-1416Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00191738472024-10-01Drug product2015-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00176589442024-12-09Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00281241252024-10-01U-1234Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00284810782024-10-01U-1416Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00291738472024-10-01Drug product2015-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022118-00276589442024-12-09Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022118-00181241252024-10-01U-1234Drug product2012-03-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00184810782024-10-01U-1416Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00191738472024-10-01Drug product2015-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00176589442024-12-09Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00281241252024-10-01U-1234Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00284810782024-10-01U-1416Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00291738472024-10-01Drug product2015-11-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N022118-00276589442024-12-09Drug productd06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-490-90EA - Each68012-490e27d1509-3937-43bb-a811-24a0465077e012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fenofibrateACTIVE INGREDIENTU202363UOSFENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8
fenofibrateACTIVE MOIETYU202363UOSFENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XFENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30FENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8
Poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGFENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8
Polyethylene Glycol 6000INACTIVE INGREDIENT30IQX730WEFENOGLIDE (FENOFIBRATE) TABLET [SANTARUS, INC.]8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68012-490-906801204909090 TABLET in 1 BOTTLE (68012-490-90) 90 tablet2010-11-180000-00-00NoNoCurrent