Home NDC 42043-171 Fenofibrate
Product NDC 42043-171
11-digit product format 420430171
Labeler code 42043
Product ID 42043-171_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET, COATED
Route ORAL
Labeler Karalex Pharma LLC
Application ANDA076520
Marketing category ANDA
Marketing start 2009-11-20
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 160 mg/1
Pharmacologic classes Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42043-171-09 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42043-171-09 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42043-171-09 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42043-171-09 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42043-171-09 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42043-171-09 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42043-171-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42043-171-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42043-171-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42043-171-09 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42043-171-09 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42043-171-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42043-171-09 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076520-001 FENOFIBRATE FENOFIBRATE 54MG TABLET / ORAL 2007-10-25 A076520-002 FENOFIBRATE FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 A076520-003 FENOFIBRATE FENOFIBRATE 160MG TABLET / ORAL 2007-10-25
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 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076520-001 FENOFIBRATE 54MG TABLET / ORAL 2007-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076520-003 FENOFIBRATE 160MG TABLET / ORAL 2007-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076520-001 FENOFIBRATE 54MG TABLET / ORAL 2007-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076520-003 FENOFIBRATE 160MG TABLET / ORAL 2007-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076520-001 FENOFIBRATE 54MG TABLET / ORAL 2007-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076520-003 FENOFIBRATE 160MG TABLET / ORAL 2007-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076520-001 FENOFIBRATE 54MG TABLET / ORAL 2007-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076520-003 FENOFIBRATE 160MG TABLET / ORAL 2007-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076520-002 FENOFIBRATE 107MG TABLET / ORAL 2005-12-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076520-003 FENOFIBRATE 160MG TABLET / ORAL AB 2007-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076520-001 FENOFIBRATE 54MG TABLET / ORAL AB 2007-10-25 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fenofibrate ACTIVE INGREDIENT U202363UOS FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 Fenofibrate ACTIVE MOIETY U202363UOS FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 betadex INACTIVE INGREDIENT JV039JZZ3A FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 dibasic calcium phosphate dihydrate INACTIVE INGREDIENT O7TSZ97GEP FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 hypromellose INACTIVE INGREDIENT 3NXW29V3WO FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE TABLET, COATED [KARALEX PHARMA LLC] 2