FENOFIBRATE

Product NDC
51655-009
11-digit product format
516550009
Labeler code
51655
Product ID
51655-009_46dda39a-93fb-1900-e063-6294a90a96f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076509
Marketing category
ANDA
Marketing start
2014-05-07
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-009-52IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-009-52IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-009-52IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-009-52IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-009-52IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-009-52IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-009-52EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A076509-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORALAB2008-03-26
A076509-002FENOFIBRATEFENOFIBRATE160MGTABLET / ORALABRS2008-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076509-001AB
A076509-002AB

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 UTC2026-02A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076509-001FENOFIBRATE54MGTABLET / ORALAB2008-03-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A076509-002FENOFIBRATE160MGTABLET / ORALABRS2008-03-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076509-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076509-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076509-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076509-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076509-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076509-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076509-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076509-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076509-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076509-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076509-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076509-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076509-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076509-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076509-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076509-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076509-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076509-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076509-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076509-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076509-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076509-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076509-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076509-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076509-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076509-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076509-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076509-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076509-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076509-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076509-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076509-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076509-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076509-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076509-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076509-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076509-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076509-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076509-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076509-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
FENOFIBRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U202363UOSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349287Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b4447a1-8136-4258-b2c8-c5f9c1bcec92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-009-52FENOFIBRATE30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-009FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20241215_4b4447a1-8136-4258-b2c8-c5f9c1bcec92.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals LLC65f5dcad-5073-4347-9ec9-e7f350b134c42026-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATENorthwind Health Company, LLC4b4447a1-8136-4258-b2c8-c5f9c1bcec922025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
ndc (product): 51655-009
FENOFIBRATEFENOFIBRATEAvPAKd4e1d692-3c03-7406-ee06-7a6fb39ed3e72025-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.882ee82a-3c56-4173-af42-68c3aadc8aa72025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATEPD-Rx Pharmaceuticals, Inc.35ba17d9-0dd7-4f15-8f74-be5fd15f19172025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATEA-S Medication Solutions3f2b3a16-7735-487e-9a2c-e078a18df1bc2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATEA-S Medication Solutionsf937a176-3d3e-4dc6-a7d4-c1a4749c7a7f2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCfa08cf6a-d306-4979-9b23-ac7febf4fd122021-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN4b4447a1-8136-4258-b2c8-c5f9c1bcec925
349287fenofibrate 160 MG Oral TabletSCD4b4447a1-8136-4258-b2c8-c5f9c1bcec925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-009-525165500095230 TABLET in 1 BOTTLE, DISPENSING (51655-009-52) 30 tablet2014-05-07NoNoCurrent