Home NDC 63629-1514 Fenofibrate
Product NDC 63629-1514
11-digit product format 636291514
Labeler code 63629
Product ID 63629-1514_7352eff2-2c49-46e1-bf59-948ddf4ccdc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076635
Marketing category ANDA
Marketing start 2020-09-18
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 160 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 78 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076635-001 FENOFIBRATE FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 A076635-002 FENOFIBRATE FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 A076635-003 FENOFIBRATE FENOFIBRATE 160MG TABLET / ORAL 2005-10-31
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 · 129 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 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076635-001 FENOFIBRATE 54MG TABLET / ORAL 2005-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076635-003 FENOFIBRATE 160MG TABLET / ORAL 2005-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076635-001 FENOFIBRATE 54MG TABLET / ORAL AB 2005-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076635-003 FENOFIBRATE 160MG TABLET / ORAL AB 2005-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076635-001 FENOFIBRATE 54MG TABLET / ORAL AB 2005-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076635-003 FENOFIBRATE 160MG TABLET / ORAL AB 2005-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076635-001 FENOFIBRATE 54MG TABLET / ORAL AB 2005-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076635-003 FENOFIBRATE 160MG TABLET / ORAL AB 2005-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076635-001 FENOFIBRATE 54MG TABLET / ORAL AB 2005-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076635-002 FENOFIBRATE 107MG TABLET / ORAL 2005-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076635-003 FENOFIBRATE 160MG TABLET / ORAL AB 2005-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076635-001 FENOFIBRATE 54MG TABLET / ORAL AB 2005-10-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-1514-1 2020-06-20 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-2 2020-06-20 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-3 2020-06-20 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-4 2020-06-20 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-5 2020-06-20 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-1 2020-01-31 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-2 2020-01-31 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-3 2020-01-31 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-4 2020-01-31 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993 63629-1514-5 2020-01-31 These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POVIDONES INACTIVE INGREDIENT FZ989GH94E FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TALC INACTIVE INGREDIENT 7SEV7J4R1U FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FENOFIBRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-1514-1 63629151401 30 TABLET, FILM COATED in 1 BOTTLE (63629-1514-1) 2014-04-08 0000-00-00 No No Current 63629-1514-2 63629151402 90 TABLET, FILM COATED in 1 BOTTLE (63629-1514-2) 2014-04-08 0000-00-00 No No Current 63629-1514-3 63629151403 60 TABLET, FILM COATED in 1 BOTTLE (63629-1514-3) 2014-04-08 0000-00-00 No No Current 63629-1514-4 63629151404 28 TABLET, FILM COATED in 1 BOTTLE (63629-1514-4) 2014-04-08 0000-00-00 No No Current 63629-1514-5 63629151405 100 TABLET, FILM COATED in 1 BOTTLE (63629-1514-5) 2014-04-08 0000-00-00 No No Current