Home NDC 68180-363 Fenofibrate
Product NDC 68180-363
11-digit product format 681800363
Labeler code 68180
Product ID 68180-363_460a572c-5bf6-4767-a7f4-6b0156e59a6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA204019
Marketing category ANDA
Marketing start 2015-11-23
Marketing end 2022-05-31
Substance FENOFIBRATE
Active strength 160 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A204019-001 FENOFIBRATE FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 A204019-002 FENOFIBRATE FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17
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 3 · 82 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 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204019-001 FENOFIBRATE 54MG TABLET / ORAL AB 2015-08-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204019-002 FENOFIBRATE 160MG TABLET / ORAL AB 2015-08-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 FENOFIBRIC ACID ACTIVE MOIETY BGF9MN2HU1 FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-363 FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] 18 Legacy NDC 20250316_4cb6617c-f787-470f-81d8-0aba46df937f.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 · 3 matching rows.
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 68180-363-02 68180036302 500 TABLET in 1 BOTTLE (68180-363-02) 500 tablet 2015-11-23 2022-05-31 No No Current 68180-363-03 68180036303 1000 TABLET in 1 BOTTLE (68180-363-03) 1000 tablet 2015-11-23 2022-05-31 No No Current 68180-363-09 68180036309 90 TABLET in 1 BOTTLE (68180-363-09) 90 tablet 2015-11-23 2022-05-31 No No Current 68180-363-13 68180036313 10 BLISTER PACK in 1 CARTON (68180-363-13) > 10 TABLET in 1 BLISTER PACK (68180-363-11) 10 blister pack 2015-11-23 2022-05-31 No No Current