FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
68788-7816
11-digit product format
687887816
Labeler code
68788
Product ID
68788-7816_9c3e35cf-cced-481b-8649-186d9be6b440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213864
Marketing category
ANDA
Marketing start
2020-11-06
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
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
ndc (product): 68788-7816
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

Additional Listing Data#

Finished product
Yes
Brand name base
FENOFIBRATE
Listing expiration
2027-12-31

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
e573b3f1-5a4c-4a19-9f0f-ee797b379a08Available 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
68788-7816-3FENOFIBRATE30 in 1 BOTTLETABLET307
68788-7816-9FENOFIBRATE60 in 1 BOTTLETABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7816-3EA - Each68788-78166123a904-565e-4eca-888b-214aa2cbac2012021-01-08
68788-7816-9EA - Each68788-781621051c4b-f39f-4a06-a3f3-b0dfa16f831c12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7816FENOFIBRATE TABLET [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20250514_e573b3f1-5a4c-4a19-9f0f-ee797b379a08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNe573b3f1-5a4c-4a19-9f0f-ee797b379a087
349287fenofibrate 160 MG Oral TabletSCDe573b3f1-5a4c-4a19-9f0f-ee797b379a087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7816-36878878160330 TABLET in 1 BOTTLE (68788-7816-3) 30 tablet2020-11-060000-00-00NoNoCurrent
68788-7816-96878878160960 TABLET in 1 BOTTLE (68788-7816-9) 60 tablet2020-11-060000-00-00NoNoCurrent