Home NDC 35561-346 Fenofibrate
Product NDC 35561-346
11-digit product format 355610346
Labeler code 35561
Product ID 35561-346_5097ee14-8bcd-10bb-e063-6394a90aa196
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENOFIBRATE
Dosage form CAPSULE
Route ORAL
Labeler Bostal LLC
Application ANDA207805
Marketing category ANDA
Marketing start 2017-11-17
Substance FENOFIBRATE
Active strength 134 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 1 .
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 A207805-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL AB 2017-11-16 A207805-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL AB 2017-11-16 A207805-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL AB 2017-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207805-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2017-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207805-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2017-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207805-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2017-11-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fenofibrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 134 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200311 Internal RxNorm lookup 310288 Internal RxNorm lookup 310289 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 35561-346-11 Fenofibrate 90 in 1 BOTTLE CAPSULE 90 10 35561-346-12 Fenofibrate 100 in 1 BOTTLE CAPSULE 100 10 35561-346-13 Fenofibrate 500 in 1 BOTTLE CAPSULE 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35561-346 FENOFIBRATE CAPSULE [AUSTARPHARMA, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20230126_a5bc232c-ff27-f8b6-e053-2995a90ad399.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.
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 35561-346-11 35561034611 90 CAPSULE in 1 BOTTLE (35561-346-11) 90 capsule 2017-11-17 0000-00-00 No No Current 35561-346-12 35561034612 100 CAPSULE in 1 BOTTLE (35561-346-12) 100 capsule 2020-11-20 0000-00-00 No No Current 35561-346-13 35561034613 500 CAPSULE in 1 BOTTLE (35561-346-13) 500 capsule 2020-11-20 No No Current