Home NDC 63304-444 Fenofibrate
Product NDC 63304-444
11-digit product format 633040444
Labeler code 63304
Product ID 63304-444_54973b69-606a-d32e-e063-6394a90a997b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA201748
Marketing category ANDA
Marketing start 2015-03-02
Substance FENOFIBRATE
Active strength 130 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201748-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE / ORAL 2014-10-31 A201748-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE / ORAL 2014-10-31
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 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 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
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 130 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 483425 Internal RxNorm lookup 483427 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 63304-444-05 Fenofibrate 500 in 1 BOTTLE CAPSULE 500 11 63304-444-30 Fenofibrate 30 in 1 BOTTLE CAPSULE 30 11 63304-444-90 Fenofibrate 90 in 1 BOTTLE CAPSULE 90 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-444 FENOFIBRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20240830_2083f5d9-92f2-4c64-b996-fabbd6946ea0.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 63304-444-05 63304044405 500 CAPSULE in 1 BOTTLE (63304-444-05) 500 capsule 2015-03-02 0000-00-00 No No Current 63304-444-30 63304044430 30 CAPSULE in 1 BOTTLE (63304-444-30) 30 capsule 2015-03-02 0000-00-00 No No Current 63304-444-90 63304044490 90 CAPSULE in 1 BOTTLE (63304-444-90) 90 capsule 2015-03-02 0000-00-00 No No Current