Home NDC 68071-1712-9 fenofibrate
Product NDC 68071-1712
Requested package NDC 68071-1712-9
11-digit product format 680711712
Labeler code 68071
Product ID 68071-1712_2d82d34c-f041-3bca-e063-6394a90ad6d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fenofibrate
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA211122
Marketing category ANDA
Marketing start 2022-07-18
Substance FENOFIBRATE
Active strength 145 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-1712 68071-1712-9 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-1712 68071-1712-9 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-1712 68071-1712-9 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A211122-001 FENOFIBRATE FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 A211122-002 FENOFIBRATE FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18
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 · 74 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 2026-02-19 14:30 UTC 2026-02 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211122-001 FENOFIBRATE 48MG TABLET / ORAL AB 2020-03-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211122-002 FENOFIBRATE 145MG TABLET / ORAL AB 2020-03-18 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base fenofibrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 145 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 477560 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-1712-9 fenofibrate 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-1712 FENOFIBRATE TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 1 package rows 20250209_f5df1da5-e390-42e4-e053-2a95a90aa8ea.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 68071-1712-9 68071171209 90 TABLET in 1 BOTTLE (68071-1712-9) 90 tablet 2023-03-01 No No Current