Home NDC 63629-7213-2 Fenofibrate
Product NDC 63629-7213
Requested package NDC 63629-7213-2
11-digit product format 636297213
Labeler code 63629
Product ID 63629-7213_ffe2b024-fc89-411a-b22d-acb976022dd4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021656
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-02-09
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 48 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
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 N021656-001 TRICOR FENOFIBRATE 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 N021656-002 TRICOR FENOFIBRATE 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05
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 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021656-002 TRICOR 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021656-002 TRICOR 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021656-002 TRICOR 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021656-001 TRICOR 48MG TABLET / ORAL RLD 2004-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021656-002 TRICOR 145MG TABLET / ORAL RLD 2004-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021656-001 TRICOR 48MG TABLET / ORAL AB RLD 2004-11-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021656-002 TRICOR 145MG TABLET / ORAL AB RLD, RS 2004-11-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 108 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7213-1 2024-01-30 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-2 2024-01-30 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-3 2024-01-30 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-1 2020-10-16 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-2 2020-10-16 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-3 2020-10-16 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-1 2020-01-31 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-2 2020-01-31 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993 63629-7213-3 2020-01-31 These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7213-1 Fenofibrate 30 in 1 BOTTLE TABLET 30 8 63629-7213-2 Fenofibrate 90 in 1 BOTTLE TABLET 90 8 63629-7213-3 Fenofibrate 28 in 1 BOTTLE TABLET 28 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7213 FENOFIBRATE TABLET [BRYANT RANCH PREPACK] 8 Legacy NDC, 3 package rows 20220115_ffe2b024-fc89-411a-b22d-acb976022dd4.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tricor FENOFIBRATE A-S Medication Solutions 84b2af1b-365e-4723-ac5f-bc826ec47772 2024-04-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 021656 application number: NDA021656
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 63629-7213-2 63629721302 90 TABLET in 1 BOTTLE (63629-7213-2) 90 tablet 2017-03-14 0000-00-00 No No Current