FIBRICOR

Product NDC
13310-102
11-digit product format
133100102
Labeler code
13310
Product ID
13310-102_26bcf80c-8314-4e10-b32c-452dbce94f7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
AR Scientific, Inc.
Application
NDA022418
Marketing category
NDA
Marketing start
2009-08-14
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
105 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13310-102IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-01IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-03IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-05IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-06IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-07IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-10IInactivated by FDA2026-08-17
excluded packagepackage13310-10213310-102-90IInactivated 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 3 · 176 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 packagepackage13310-102-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13310-102-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13310-102-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13310-102-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13310-102-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13310-102-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13310-102-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13310-102-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13310-102-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13310-102-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13310-102-10ed331223b511…672a5bd82f5f…

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#

NDC, Related label table
NDCRelated label
13310-102-01These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-03These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-05These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-06These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-07These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-10These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-102-90These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13310-102-01FIBRICOR100 in 1 BOTTLE, PLASTICTABLET10013
13310-102-03FIBRICOR250 in 1 BOTTLE, PLASTICTABLET25013
13310-102-05FIBRICOR500 in 1 BOTTLE, PLASTICTABLET50013
13310-102-06FIBRICOR60 in 1 BOTTLE, PLASTICTABLET6013
13310-102-07FIBRICOR30 in 1 BOTTLE, PLASTICTABLET3013
13310-102-10FIBRICOR1000 in 1 BOTTLE, PLASTICTABLET100013
13310-102-90FIBRICOR90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13310-102-07EA - Each13310-1022e03eff6-96f0-4234-b150-9350c80a605312012-07-24
13310-102-90EA - Each13310-10220b172ab-cc99-4042-84cb-8609435b91a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fenofibric AcidACTIVE INGREDIENTBGF9MN2HU1FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
Fenofibric AcidACTIVE MOIETYBGF9MN2HU1FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
copovidone K25-31INACTIVE INGREDIENTD9C330MD8BFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
crospovidoneINACTIVE INGREDIENT68401960MKFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
magnesium stearateINACTIVE INGREDIENT70097M6I30FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13310-102FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13Legacy NDC, 7 package rows20130321_86c49aff-0a4a-46b5-ac6e-26789bf17c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860886fenofibric acid 35 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884FIBRICOR 105 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888FIBRICOR 35 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884fenofibric acid 105 MG Oral Tablet [Fibricor]SBD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888fenofibric acid 35 MG Oral Tablet [Fibricor]SBD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860880fenofibric acid 105 MG Oral TabletSCD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860886fenofibric acid 35 MG Oral TabletSCD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884Fibricor (fenofibric acid 105 MG) Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888Fibricor (fenofibric acid 35 MG) Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884Fibricor 105 MG Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888Fibricor 35 MG Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13310-102-0113310010201100 in 1 BOTTLE, PLASTICHistorical
13310-102-0313310010203250 in 1 BOTTLE, PLASTICHistorical
13310-102-0513310010205500 in 1 BOTTLE, PLASTICHistorical
13310-102-061331001020660 in 1 BOTTLE, PLASTICHistorical
13310-102-071331001020730 in 1 BOTTLE, PLASTICHistorical
13310-102-10133100102101000 in 1 BOTTLE, PLASTICHistorical
13310-102-901331001029090 in 1 BOTTLE, PLASTICHistorical