Home NDC 42385-935 FENOFIBRATE
Product NDC 42385-935
11-digit product format 423850935
Labeler code 42385
Product ID 42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENOFIBRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA210606
Marketing category ANDA
Marketing start 2020-01-13
Substance FENOFIBRATE
Active strength 54 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 1 .
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 A210606-001 FENOFIBRATE FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 A210606-002 FENOFIBRATE FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210606-001 FENOFIBRATE 54MG TABLET / ORAL 2018-08-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210606-002 FENOFIBRATE 160MG TABLET / ORAL 2018-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210606-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-08-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210606-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-08-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FENOFIBRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 54 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 349287 Internal RxNorm lookup 351133 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 42385-935-05 FENOFIBRATE 500 in 1 BOTTLE TABLET, FILM COATED 500 4 42385-935-11 FENOFIBRATE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 42385-935-30 FENOFIBRATE 30 in 1 BOTTLE TABLET, FILM COATED 30 4 42385-935-90 FENOFIBRATE 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-935 FENOFIBRATE (FENOFIBRATE) TABLET, FILM COATED [LAURUS LABS LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221229_8e58c13a-8088-4fed-86cc-52530de5aa45.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 Marketing start Marketing end Sample Exclude flag Status 42385-935-05 42385093505 500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05) 2020-01-13 0000-00-00 No No Current 42385-935-11 42385093511 1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11) 2020-01-13 0000-00-00 No No Current 42385-935-30 42385093530 30 TABLET, FILM COATED in 1 BOTTLE (42385-935-30) 2020-01-13 0000-00-00 No No Current 42385-935-90 42385093590 90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90) 2020-01-13 0000-00-00 No No Current