Home NDC 62559-461 Fenofibrate
Product NDC 62559-461
11-digit product format 625590461
Labeler code 62559
Product ID 62559-461_9938193b-bd47-4176-9e2e-840f09112fff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA021612
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-13
Substance FENOFIBRATE
Active strength 150 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 N021612-001 LIPOFEN FENOFIBRATE 50MG CAPSULE / ORAL RLD 2006-01-11 N021612-002 LIPOFEN FENOFIBRATE 100MG CAPSULE / ORAL RLD 2006-01-11 N021612-003 LIPOFEN FENOFIBRATE 150MG CAPSULE / ORAL RLD, RS 2006-01-11
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 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021612-002 LIPOFEN 100MG CAPSULE / ORAL RLD 2006-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021612-002 LIPOFEN 100MG CAPSULE / ORAL RLD 2006-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021612-002 LIPOFEN 100MG CAPSULE / ORAL RLD 2006-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021612-002 LIPOFEN 100MG CAPSULE / ORAL 2006-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021612-003 LIPOFEN 150MG CAPSULE / ORAL RLD, RS 2006-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021612-001 LIPOFEN 50MG CAPSULE / ORAL RLD 2006-01-11 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fenofibrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 150 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 616852 Internal RxNorm lookup 616853 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 62559-461-90 Fenofibrate 90 in 1 BOTTLE CAPSULE 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-461 FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20211216_3a69e15a-eda6-4a6e-8934-6881e4370521.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 · 2 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 62559-461-90 62559046190 90 CAPSULE in 1 BOTTLE (62559-461-90) 90 capsule 2016-04-13 0000-00-00 No No Current