Home NDC 50090-8096-0 Fenofibrate
Product NDC 50090-8096
Requested package NDC 50090-8096-0
11-digit product format 500908096
Labeler code 50090
Product ID 50090-8096_15784e98-f6db-4388-8479-990de4397f48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA213842
Marketing category ANDA
Marketing start 2020-10-22
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 45 .
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 A213842-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL AB 2020-10-19 A213842-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL AB 2020-10-19 A213842-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL AB 2020-10-19
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 3 · 120 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 2026-11-14 07:37:17 2026-10 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213842-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2020-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213842-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2020-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213842-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2020-10-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310288 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8096-0 50090809600 90 CAPSULE in 1 BOTTLE (50090-8096-0) 90 capsule 2026-10-01 No No Current