Home NDC 0378-4390 Fenofibrate
Product NDC 0378-4390
11-digit product format 003784390
Labeler code 0378
Product ID 0378-4390_beac0c72-4b03-4b72-9568-db8a22571fe0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA204475
Marketing category ANDA
Marketing start 2016-06-23
Substance FENOFIBRATE
Active strength 40 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A204475-001 FENOFIBRATE FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 A204475-002 FENOFIBRATE FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB RS 2016-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204475-001 FENOFIBRATE 40MG TABLET / ORAL AB 2016-06-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204475-002 FENOFIBRATE 120MG TABLET / ORAL AB 2016-06-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fenofibrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U202363UOS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749802 Internal RxNorm lookup 749804 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-4390-77 Fenofibrate 90 in 1 BOTTLE, PLASTIC TABLET 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4390 FENOFIBRATE TABLET [MYLAN PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240208_5b67f389-55e8-466b-82bd-5ea992f630aa.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-4390-77 00378439077 90 TABLET in 1 BOTTLE, PLASTIC (0378-4390-77) 90 tablet 2016-06-23 0000-00-00 No No Current