Home NDC 82619-102 FENOFIBRATE
Product NDC 82619-102
11-digit product format 826190102
Labeler code 82619
Product ID 82619-102_40b943ae-a94c-308c-e063-6294a90a6413
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form TABLET
Route ORAL
Labeler Creekwood Pharmaceuticals LLC
Application ANDA217732
Marketing category ANDA
Marketing start 2023-09-07
Substance FENOFIBRATE
Active strength 120 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 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 A217732-001 FENOFIBRATE FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 A217732-002 FENOFIBRATE FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07
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 2 · 44 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 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217732-001 FENOFIBRATE 40MG TABLET / ORAL BX 2023-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217732-002 FENOFIBRATE 120MG TABLET / ORAL BX 2023-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217732-001 FENOFIBRATE 40MG TABLET / ORAL AB 2023-09-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217732-002 FENOFIBRATE 120MG TABLET / ORAL AB 2023-09-07 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 120 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 749802 Internal RxNorm lookup 749804 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 82619-102-01 FENOFIBRATE 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82619-102 FENOFIBRATE TABLET [CREEKWOOD PHARMACEUTICALS LLC] 2 Current NDC, 1 package rows 20241016_65d8aefc-7ec2-4f62-9254-5f0070c58ac2.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82619-102-01 82619010201 90 TABLET in 1 BOTTLE (82619-102-01) 90 tablet 2023-09-20 No No Current