Home NDC 43353-032 Tricor
Product NDC 43353-032
11-digit product format 433530032
Labeler code 43353
Product ID 43353-032_159645df-cd6b-46a3-842b-2d50c920a8de
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 2004-11-05
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 145 mg/1
Pharmacologic classes Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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Approval date N021656-001 TRICOR FENOFIBRATE 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 N021656-002 TRICOR FENOFIBRATE 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05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 · 86 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 2026-09-14 22:38:34 2026-08 N021656-001 TRICOR 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021656-002 TRICOR 145MG **Federal Register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 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 56 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 108 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-032-83 Tricor 3600 in 1 BOTTLE, PLASTIC TABLET 3600 2 43353-032-98 Tricor 540 in 1 BOTTLE, PLASTIC TABLET 540 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENOFIBRATE ACTIVE INGREDIENT U202363UOS TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FENOFIBRATE ACTIVE MOIETY U202363UOS TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-032 TRICOR (FENOFIBRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 2 package rows 20140611_ddb63851-e9b9-4ab0-8e6d-6f83d79741e5.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 Status 43353-032-83 43353003283 3600 in 1 BOTTLE, PLASTIC Historical 43353-032-98 43353003298 540 in 1 BOTTLE, PLASTIC Historical