Tricor

Product NDC
0074-3189
11-digit product format
000743189
Labeler code
0074
Product ID
0074-3189_7d6fd4ec-c931-458a-8687-fd3a96dfda2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA021656
Marketing category
NDA
Marketing start
2016-02-05
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0074-3189DDiscontinued by firm2026-08-10
excluded packagepackage0074-31890074-3189-90DDiscontinued by firm2026-08-10

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
N021656-001TRICORFENOFIBRATE48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05
N021656-002TRICORFENOFIBRATE145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05

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 UTC2026-02N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021656-001TRICOR48MGTABLET / ORALRLD2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021656-002TRICOR145MGTABLET / ORALRLD2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021656-001TRICOR48MGTABLET / ORALRLD2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021656-002TRICOR145MGTABLET / ORALRLD2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021656-001TRICOR48MGTABLET / ORALRLD2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021656-002TRICOR145MGTABLET / ORALRLD2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-002TRICOR145MGTABLET / ORALRLD2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-002TRICOR145MGTABLET / ORALRLD2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021656-002TRICOR145MGTABLET / ORALRLD2004-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021656-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021656-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021656-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021656-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021656-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021656-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N021656-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021656-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021656-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021656-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021656-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021656-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021656-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021656-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021656-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021656-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021656-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021656-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021656-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021656-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021656-002AB19b2671bbb829…

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00172762492023-02-21Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00173208022023-02-21U-8475c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00272762492023-02-21Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00273208022023-02-21U-8475c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-00172762492023-02-21Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00173208022023-02-21U-8475d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00272762492023-02-21Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00273208022023-02-21U-8475d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-00172762492023-02-21Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00173208022023-02-21U-8474b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00272762492023-02-21Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00273208022023-02-21U-8474b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-00163759862020-09-21U-615Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00172762492023-02-21Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00173208022023-02-21U-84774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00263759862020-09-21U-615Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00272762492023-02-21Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00273208022023-02-21U-84774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-00172762492023-02-21Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00173208022023-02-21U-847bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00272762492023-02-21Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00273208022023-02-21U-847bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-00172762492023-02-21Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00173208022023-02-21U-847782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00272762492023-02-21Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00273208022023-02-21U-847782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00172762492023-02-21Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00173208022023-02-21U-84787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00272762492023-02-21Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00273208022023-02-21U-84787673890dc5c…
2021-03-12 10:30 UTC2021-03N021656-00172762492023-02-21Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00173208022023-02-21U-8475aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00272762492023-02-21Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00273208022023-02-21U-8475aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021656-00163759862020-09-21U-615Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00172762492023-02-21Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00173208022023-02-21U-8478869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00263759862020-09-21U-615Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00272762492023-02-21Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00273208022023-02-21U-8478869cabd3fbd…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FENOFIBRATEACTIVE MOIETYU202363UOSTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
SUCROSEINACTIVE INGREDIENTC151H8M554TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
TALCINACTIVE INGREDIENT7SEV7J4R1UTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3189TRICOR (FENOFIBRATE) TABLET [ABBVIE INC.]1516Legacy NDC20241122_b693e68d-f812-4993-54b6-852e3517c344.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricorFENOFIBRATEA-S Medication Solutions84b2af1b-365e-4723-ac5f-bc826ec477722024-04-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021656
application number: NDA021656

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN84b2af1b-365e-4723-ac5f-bc826ec4777211
540281TriCor 145 MG Oral TabletPSN84b2af1b-365e-4723-ac5f-bc826ec4777211
540281fenofibrate 145 MG Oral Tablet [Tricor]SBD84b2af1b-365e-4723-ac5f-bc826ec4777211
477560fenofibrate 145 MG Oral TabletSCD84b2af1b-365e-4723-ac5f-bc826ec4777211
540281Tricor 145 MG Oral TabletSY84b2af1b-365e-4723-ac5f-bc826ec4777211
477560fenofibrate 145 MG Oral TabletPSN70275d9c-a321-4561-adbf-60b555718ce21
540281TriCor 145 MG Oral TabletPSN70275d9c-a321-4561-adbf-60b555718ce21
540281fenofibrate 145 MG Oral Tablet [Tricor]SBD70275d9c-a321-4561-adbf-60b555718ce21
477560fenofibrate 145 MG Oral TabletSCD70275d9c-a321-4561-adbf-60b555718ce21
540281Tricor 145 MG Oral TabletSY70275d9c-a321-4561-adbf-60b555718ce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3189-900007431899090 TABLET in 1 BOTTLE (0074-3189-90) 90 tablet2016-02-050000-00-00NoNoCurrent