Home NDC 0378-7100 Fenofibrate
Product NDC 0378-7100
11-digit product format 003787100
Labeler code 0378
Product ID 0378-7100_7a2b1694-b5f5-4e1b-b14e-c7abb1e76545
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA076520
Marketing category ANDA
Marketing start 2009-12-22
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 54 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-7100-77 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-7100-77 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-7100-77 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-7100-77 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-7100-77 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-7100-77 cdf11ea48f46…ba0047e9e063…
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, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 BETADEX INACTIVE INGREDIENT JV039JZZ3A FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-7100-77 00378710077 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7100-77) 2009-12-22 0000-00-00 No No Current