Home NDC 60505-3120 Fenofibrate
Product NDC 60505-3120
11-digit product format 605053120
Labeler code 60505
Product ID 60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA202252
Marketing category ANDA
Marketing start 2013-07-26
Substance FENOFIBRATE
Active strength 43 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 A202252-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE / ORAL AB 2013-07-26 A202252-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE / ORAL AB 2013-07-26
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 A202252-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL AB 2013-07-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A202252-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL AB 2013-07-26 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 A202252-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A202252-002 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 43 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 483425 Internal RxNorm lookup 483427 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 60505-3120-1 Fenofibrate 100 in 1 BOTTLE CAPSULE 100 14 60505-3120-3 Fenofibrate 30 in 1 BOTTLE CAPSULE 30 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3120 FENOFIBRATE CAPSULE [APOTEX CORP.] 12 Current NDC, Legacy NDC, 2 package rows 20240927_68024459-987a-9cf4-f539-4959093bc9f0.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 60505-3120-1 60505312001 100 CAPSULE in 1 BOTTLE (60505-3120-1) 100 capsule 2013-07-26 0000-00-00 No No Current 60505-3120-3 60505312003 30 CAPSULE in 1 BOTTLE (60505-3120-3) 30 capsule 2013-07-26 0000-00-00 No No Current