Home NDC 62135-894 fenofibrate
Product NDC 62135-894
11-digit product format 621350894
Labeler code 62135
Product ID 62135-894_459be037-d59a-9ee0-e063-6394a90a3b5e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA211407
Marketing category ANDA
Marketing start 2024-01-31
Substance FENOFIBRATE
Active strength 134 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211407-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL AB 2024-01-31 A211407-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL AB 2024-01-31 A211407-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL AB 2024-01-31
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 2 · 57 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 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200311 Internal RxNorm lookup 310288 Internal RxNorm lookup 310289 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 62135-894-90 fenofibrate 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-894 FENOFIBRATE CAPSULE [CHARTWELL RX, LLC.] 1 Current NDC, 1 package rows 20240922_2d0cfddc-ace3-4187-8d94-d760d23d20b6.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 · 1 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 62135-894-90 62135089490 90 CAPSULE in 1 BOTTLE (62135-894-90) 90 capsule 2024-09-12 No No Current