Home NDC 69238-1262 Fenofibrate
Product NDC 69238-1262
11-digit product format 692381262
Labeler code 69238
Product ID 69238-1262_83cbfdb7-7c9b-437a-95da-c0a800e7cb60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA209950
Marketing category ANDA
Marketing start 2018-03-23
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 A209950-001 FENOFIBRATE FENOFIBRATE 54MG TABLET / ORAL AB 2018-03-19 A209950-002 FENOFIBRATE FENOFIBRATE 160MG TABLET / ORAL AB 2018-03-19
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.
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 2026-08-01 22:54:32 2026-06 A209950-001 FENOFIBRATE 54MG TABLET / ORAL AB 2018-03-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A209950-002 FENOFIBRATE 160MG TABLET / ORAL AB 2018-03-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A209950-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209950-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 69238-1262-9 Fenofibrate 90 in 1 BOTTLE TABLET 90 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1262 FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS NY LLC] 21 Current NDC, Legacy NDC, 1 package rows 20231231_7e79d495-5d59-485e-b3c2-7c31ba044948.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 69238-1262-9 69238126209 90 TABLET in 1 BOTTLE (69238-1262-9) 90 tablet 2018-03-23 0000-00-00 No No Current