Home NDC 43353-272 Tricor
Product NDC 43353-272
11-digit product format 433530272
Labeler code 43353
Product ID 43353-272_3e47ea73-8fb6-4624-9dad-de04d8d650de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021656
Marketing category NDA
Marketing start 2016-02-05
Substance FENOFIBRATE
Active strength 145 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 42 .
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Approval date N021656-001 TRICOR FENOFIBRATE 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 N021656-002 TRICOR FENOFIBRATE 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05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 · 84 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 2026-08-18 06:07:40 2026-07 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021656-002 TRICOR 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021656-002 TRICOR 145MG **Federal Register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…
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-272-30 Tricor 30 in 1 BOTTLE TABLET 30 1 43353-272-83 Tricor 3600 in 1 BOTTLE TABLET 3600 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-272 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20171013_70275d9c-a321-4561-adbf-60b555718ce2.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 43353-272-30 43353027230 30 TABLET in 1 BOTTLE (43353-272-30) 30 tablet 2017-01-27 0000-00-00 No No Current 43353-272-83 43353027283 3600 TABLET in 1 BOTTLE (43353-272-83) 3600 tablet 2017-01-27 0000-00-00 No No Current