Fenofibrate

Product NDC
65862-769
Requested package NDC
65862-769-15
11-digit product format
658620769
Labeler code
65862
Product ID
65862-769_05013562-2f49-4b1f-a8eb-5925f3d3bead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205118
Marketing category
ANDA
Marketing start
2016-05-05
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-76965862-769-15UNFINISHEDActive or certified unfinished drug listing2026-08-10

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A205118-001FENOFIBRATEFENOFIBRATE48MGTABLET / ORALAB2016-05-05
A205118-002FENOFIBRATEFENOFIBRATE145MGTABLET / ORALABRS2016-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205118-001AB
A205118-002AB

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 UTC2026-02A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205118-002FENOFIBRATE145MGTABLET / ORALABRS2016-05-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205118-001FENOFIBRATE48MGTABLET / ORALAB2016-05-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A205118-002FENOFIBRATE145MGTABLET / ORALAB2016-05-05782e0a99824c…

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 UTC2026-02A205118-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205118-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205118-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205118-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205118-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205118-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205118-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205118-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205118-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205118-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205118-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205118-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205118-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205118-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205118-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205118-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205118-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205118-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205118-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205118-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205118-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205118-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205118-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205118-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205118-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205118-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205118-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205118-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205118-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205118-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205118-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205118-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205118-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205118-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205118-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205118-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205118-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205118-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205118-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205118-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE145 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
477560Internal RxNorm lookup
477562Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84fcea7a-05ed-44c2-98fa-7e87b28d2261Available 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
65862-769-01Fenofibrate100 in 1 BOTTLETABLET, COATED1009
65862-769-05Fenofibrate500 in 1 BOTTLETABLET, COATED5009
65862-769-10Fenofibrate10 in 1 BLISTER PACKTABLET, COATED109
65862-769-78Fenofibrate10 in 1 CARTONTABLET, COATED109
65862-769-90Fenofibrate90 in 1 BOTTLETABLET, COATED909
65862-769-99Fenofibrate1000 in 1 BOTTLETABLET, COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-769-90EA - Each65862-769ab0ac2ec-05c3-4777-bca8-293f5514460b12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-769FENOFIBRATE TABLET, COATED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 6 package rows20250221_84fcea7a-05ed-44c2-98fa-7e87b28d2261.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATENuCare Pharmaceuticals,Inc.bdc2211e-6d65-1500-e053-2a95a90ab1452026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205118
application number: ANDA205118
FenofibrateFENOFIBRATEBryant Ranch Prepackba8e809e-f6b5-4ba8-9108-81cc82b142252025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205118
application number: ANDA205118
FenofibrateFENOFIBRATEQUALLENT PHARMACEUTICALS HEALTH LLC215a5000-9f89-47d9-b2d5-94e13f5e17672025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205118
application number: ANDA205118
FenofibrateFENOFIBRATEAurobindo Pharma Limited84fcea7a-05ed-44c2-98fa-7e87b28d22612025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205118
application number: ANDA205118
ndc (product): 65862-769
FenofibrateFENOFIBRATEA-S Medication Solutionsd0c7070e-b3bb-4b5b-8a62-4e3136b5accc2024-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205118
application number: ANDA205118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN84fcea7a-05ed-44c2-98fa-7e87b28d22619
477562fenofibrate 48 MG Oral TabletPSN84fcea7a-05ed-44c2-98fa-7e87b28d22619
477560fenofibrate 145 MG Oral TabletSCD84fcea7a-05ed-44c2-98fa-7e87b28d22619
477562fenofibrate 48 MG Oral TabletSCD84fcea7a-05ed-44c2-98fa-7e87b28d22619
477560fenofibrate 145 MG Oral TabletPSN4ee0da76-e11f-4dec-891a-579f7a36b5681
477560fenofibrate 145 MG Oral TabletSCD4ee0da76-e11f-4dec-891a-579f7a36b5681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-769-15658620769151500 TABLET, COATED in 1 BAG (65862-769-15)05-MAY-16Current