Home NDC 68071-3114 fenofibrate
Product NDC 68071-3114
11-digit product format 680713114
Labeler code 68071
Product ID 68071-3114_bb13437d-35f4-fdff-e053-2995a90aff8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA090715
Marketing category ANDA
Marketing start 2014-09-23
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 145 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 45 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 68071-3114-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-3114-2 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 68071-3114-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-3114-2 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-3114-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-3114-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-3114-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-3114-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-3114-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-3114-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-3114-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-3114-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090715-001 FENOFIBRATE FENOFIBRATE 48MG TABLET / ORAL 2012-04-05 A090715-002 FENOFIBRATE FENOFIBRATE 145MG TABLET / ORAL 2012-04-05
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 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 A090715-001 FENOFIBRATE 48MG TABLET / ORAL 2012-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090715-002 FENOFIBRATE 145MG TABLET / ORAL 2012-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090715-001 FENOFIBRATE 48MG TABLET / ORAL 2012-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090715-002 FENOFIBRATE 145MG TABLET / ORAL 2012-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090715-001 FENOFIBRATE 48MG TABLET / ORAL AB 2012-04-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090715-002 FENOFIBRATE 145MG TABLET / ORAL AB 2012-04-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68071-3114-2 2024-08-15 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-3 2024-08-15 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-2 2023-01-30 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-3 2023-01-30 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-2 2021-02-11 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-3 2021-02-11 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-2 2021-01-29 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 68071-3114-3 2021-01-29 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-3114-2 68071311402 20 TABLET in 1 BOTTLE (68071-3114-2) 20 tablet 2017-03-10 0000-00-00 No No Current 68071-3114-3 68071311403 30 TABLET in 1 BOTTLE (68071-3114-3) 30 tablet 2017-03-10 0000-00-00 No No Current