FIBRICOR

Product NDC
70347-035
11-digit product format
703470035
Labeler code
70347
Product ID
70347-035_3f1da578-fd1e-4f75-b179-98bd4aef4178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Aralez Pharmaceuticals US Inc.
Application
NDA022418
Marketing category
NDA
Marketing start
2017-08-05
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
35 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct70347-035IInactivated by FDA2026-08-17
excluded packagepackage70347-03570347-035-30IInactivated by FDA2026-08-17

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70347-035-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70347-035-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70347-035-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70347-035-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70347-035-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70347-035-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70347-035-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70347-035-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70347-035-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70347-035-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70347-035-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70347-035-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70347-035-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70347-035-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70347-035-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70347-035-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70347-035-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70347-035-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70347-035-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70347-035-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70347-035-309bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022418-001FIBRICORFENOFIBRIC ACID35MGTABLET / ORALRLD2009-08-14
N022418-002FIBRICORFENOFIBRIC ACID105MGTABLET / ORALRLD2009-08-14

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022418-00175696122027-08-20U-1000
N022418-00177413732027-08-20U-1059
N022418-00177413742027-08-20U-1060
N022418-00177413742027-08-20U-1061
N022418-00179152472027-08-20U-10002011-03-30
N022418-00179152472027-08-20U-10592011-03-30
N022418-00179152472027-08-20U-10612011-03-30
N022418-00275696122027-08-20U-1000
N022418-00277413732027-08-20U-1059
N022418-00277413742027-08-20U-1060
N022418-00277413742027-08-20U-1061
N022418-00279152472027-08-20U-1000
N022418-00279152472027-08-20U-1059
N022418-00279152472027-08-20U-1061

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022418-002FIBRICOR105MGTABLET / ORALRLD2009-08-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022418-001FIBRICOR35MGTABLET / ORALRLD2009-08-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022418-002FIBRICOR105MGTABLET / ORALRLD, RS2009-08-14bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022418-00175696122027-08-20U-1000caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00177413732027-08-20U-1059caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00177413742027-08-20U-1061caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00177413742027-08-20U-1060caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00179152472027-08-20U-10612011-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00179152472027-08-20U-10592011-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00179152472027-08-20U-10002011-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00275696122027-08-20U-1000caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00277413732027-08-20U-1059caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00277413742027-08-20U-1061caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00277413742027-08-20U-1060caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00279152472027-08-20U-1000caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00279152472027-08-20U-1059caaa826d4ba7…
2026-08-18 06:07:402026-07N022418-00279152472027-08-20U-1061caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022418-00175696122027-08-20U-1000011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00177413732027-08-20U-1059011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00177413742027-08-20U-1061011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00177413742027-08-20U-1060011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00179152472027-08-20U-10612011-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00179152472027-08-20U-10592011-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00179152472027-08-20U-10002011-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00275696122027-08-20U-1000011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00277413732027-08-20U-1059011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00277413742027-08-20U-1061011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00277413742027-08-20U-1060011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00279152472027-08-20U-1000011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00279152472027-08-20U-1059011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022418-00279152472027-08-20U-1061011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00175696122027-08-20U-100031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00177413732027-08-20U-105931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00177413742027-08-20U-106131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00177413742027-08-20U-106031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00179152472027-08-20U-10612011-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00179152472027-08-20U-10592011-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00179152472027-08-20U-10002011-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00275696122027-08-20U-100031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00277413732027-08-20U-105931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00277413742027-08-20U-106131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00277413742027-08-20U-106031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022418-00279152472027-08-20U-100031067a03dcf5…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70347-035-30FIBRICOR30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70347-035-30EA - Each70347-0350cda18e0-9fd1-4479-aa06-b0a57e060ac912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70347-035FIBRICOR (FENOFIBRIC ACID) TABLET [ARALEZ PHARMACEUTICALS US INC.]3Legacy NDC, 1 package rows20181012_31c80f84-0169-4659-b9cf-8f897ed319eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860886fenofibric acid 35 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860884FIBRICOR 105 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860888FIBRICOR 35 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860884fenofibric acid 105 MG Oral Tablet [Fibricor]SBD31c80f84-0169-4659-b9cf-8f897ed319eb3
860888fenofibric acid 35 MG Oral Tablet [Fibricor]SBD31c80f84-0169-4659-b9cf-8f897ed319eb3
860880fenofibric acid 105 MG Oral TabletSCD31c80f84-0169-4659-b9cf-8f897ed319eb3
860886fenofibric acid 35 MG Oral TabletSCD31c80f84-0169-4659-b9cf-8f897ed319eb3
860884Fibricor (fenofibric acid 105 MG) Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860888Fibricor (fenofibric acid 35 MG) Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860884Fibricor 105 MG Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860888Fibricor 35 MG Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70347-035-307034700353030 in 1 BOTTLE, PLASTICHistorical