Home NDC 0115-0533-01 Fenofibrate
Product NDC 0115-0533
Requested package NDC 0115-0533-01
11-digit product format 001150533
Labeler code 0115
Product ID 0115-0533_4faa7be9-6cb4-4192-a287-555ad2ba3cbc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENOFIBRATE
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA075868
Marketing category ANDA
Marketing start 2010-02-01
Marketing end 0000-00-00
Substance FENOFIBRATE
Active strength 200 mg/1
Pharmacologic classes Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075868-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL 2003-10-27 A075868-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL 2003-10-27 A075868-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL 2003-10-27
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 4 · 123 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 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075868-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL 2003-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075868-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL 2003-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075868-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL 2003-10-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
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 0115-0533-01 Fenofibrate 100 in 1 BOTTLE CAPSULE 100 48 0115-0533-02 Fenofibrate 500 in 1 BOTTLE CAPSULE 500 48
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 7 FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FENOFIBRATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING] 4 FENOFIBRATE ACTIVE INGREDIENT U202363UOS FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FENOFIBRATE ACTIVE MOIETY U202363UOS FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FENOFIBRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-0533 FENOFIBRATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 48 Legacy NDC, 2 package rows 20221208_bfc6668c-3f69-4dd3-bc19-0d26c23dd04c.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 0115-0533-01 00115053301 100 CAPSULE in 1 BOTTLE (0115-0533-01) 100 capsule 2010-02-01 0000-00-00 No No Current