FENOFIBRATE

Product NDC
60219-5511
11-digit product format
602195511
Labeler code
60219
Product ID
60219-5511_cd7dc10f-f401-4e24-8be8-86aa08151ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA076509
Marketing category
ANDA
Marketing start
2022-06-22
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
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 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE54 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349287Internal RxNorm lookup
351133Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65f5dcad-5073-4347-9ec9-e7f350b134c4Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-5511-9FENOFIBRATE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-5511-9EA - Each60219-5511a9c2118f-792f-4ee0-9f93-5eee851c813c12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-5511FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 1 package rows20241210_65f5dcad-5073-4347-9ec9-e7f350b134c4.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
ndc (product): 60219-5511
FENOFIBRATEFENOFIBRATENorthwind Health Company, LLC4b4447a1-8136-4258-b2c8-c5f9c1bcec922025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076509
application number: ANDA076509
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 TabletPSNd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
351133fenofibrate 54 MG Oral TabletPSNd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
349287fenofibrate 160 MG Oral TabletSCDd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
351133fenofibrate 54 MG Oral TabletSCDd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
349287fenofibrate 160 MG Oral TabletPSN65f5dcad-5073-4347-9ec9-e7f350b134c44
351133fenofibrate 54 MG Oral TabletPSN65f5dcad-5073-4347-9ec9-e7f350b134c44
349287fenofibrate 160 MG Oral TabletSCD65f5dcad-5073-4347-9ec9-e7f350b134c44
351133fenofibrate 54 MG Oral TabletSCD65f5dcad-5073-4347-9ec9-e7f350b134c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-5511-96021955110990 TABLET in 1 BOTTLE (60219-5511-9) 90 tablet2022-06-220000-00-00NoNoCurrent