Home NDC 42858-134-01 Fenofibrate
Product NDC 42858-134
Requested package NDC 42858-134-01
11-digit product format 428580134
Labeler code 42858
Product ID 42858-134_ed6ef266-83c1-4183-83a0-a10b76a55e49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler Rhodes Pharmaceuticals LLC
Application ANDA075753
Marketing category ANDA
Marketing start 2017-06-01
Marketing end 2026-07-31
Substance FENOFIBRATE
Active strength 134 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
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 A075753-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL AB 2002-09-03 A075753-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL AB 2002-04-09 A075753-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL AB 2002-04-09
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 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075753-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2002-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075753-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2002-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075753-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2002-09-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42858-134-01 Fenofibrate 100 in 1 BOTTLE CAPSULE 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42858-134 FENOFIBRATE CAPSULE [RHODES PHARMACEUTICALS L.P.] 9 Current NDC, Legacy NDC, 1 package rows 20230325_829f5c2e-3329-4644-bccb-267afb678540.zip
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 42858-134-01 42858013401 100 CAPSULE in 1 BOTTLE (42858-134-01) 100 capsule 2017-06-01 2026-07-31 No No Current