FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
68071-2540
11-digit product format
680712540
Labeler code
68071
Product ID
68071-2540_e674720f-dc2a-0824-e053-2995a90a4cd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213864
Marketing category
ANDA
Marketing start
2020-09-10
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
160 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2540IInactivated by FDA2026-07-31
excluded packagepackage68071-254068071-2540-9IInactivated by FDA2026-07-31

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
A213864-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORALAB2020-06-12
A213864-002FENOFIBRATEFENOFIBRATE160MGTABLET / ORALAB2020-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213864-001AB
A213864-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213864-001FENOFIBRATE54MGTABLET / ORALAB2020-06-12a50c72e98297…
2026-08-01 22:54:322026-06A213864-002FENOFIBRATE160MGTABLET / ORALAB2020-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213864-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213864-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.3b6c5ebd-a8bc-4502-8b66-f4e58914815b2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATESt. Mary's Medical Park Pharmacyb92fb19a-d0df-426e-e053-2995a90ab3792026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEA-S Medication Solutionsdf9f67d6-3cd9-4f44-8020-2d6ef53c30b52026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEPreferred Pharmaceuticals Inc.e573b3f1-5a4c-4a19-9f0f-ee797b379a082026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEA-S Medication Solutionsf443dd79-46da-4b02-8188-7417d39cf9752026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.b79efcf4-6016-4a1f-b83f-be00baa25c212026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATENorthwind Health Company, LLCf7590970-c54d-24e9-e053-6294a90ac4002026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATENorthStar RxLLC3b448774-aebf-45fe-92f1-b8eca53cf09b2025-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEMajor Pharmaceuticals3f4e5db8-5bfb-4b24-8465-9757cbaad2be2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATELifestar Pharma LLC1da57e8c-3977-43e1-aa7e-229760203f7d2025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEBryant Ranch Prepackd34f9fa3-39ae-4b8e-8f29-0d5c655c50b52023-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864
FENOFIBRATEFENOFIBRATEProficient Rx LP26f8f793-fb7a-4327-9441-d8737fe1ff112022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213864
application number: ANDA213864

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2540-92025-01-30C16284748780-12cef2736-93af-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2540-9FENOFIBRATE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2540FENOFIBRATE TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 1 package rows20230715_cc85c6cc-7fd4-4013-e053-2a95a90aa5d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNcc85c6cc-7fd4-4013-e053-2a95a90aa5d13
349287fenofibrate 160 MG Oral TabletSCDcc85c6cc-7fd4-4013-e053-2a95a90aa5d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2540-96807125400990 TABLET in 1 BOTTLE (68071-2540-9) 90 tablet2021-09-210000-00-00NoNoCurrent