Fenofibrate

Product NDC
51407-092
11-digit product format
514070092
Labeler code
51407
Product ID
51407-092_c55e9d1d-d4fa-8d21-e053-2a95a90a0226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075753
Marketing category
ANDA
Marketing start
2002-04-09
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51407-092DDiscontinued by firm2026-08-10
excluded packagepackage51407-09251407-092-90DDiscontinued by firm2026-08-10

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075753-001FENOFIBRATE (MICRONIZED)FENOFIBRATE67MGCAPSULE / ORALAB2002-09-03
A075753-002FENOFIBRATE (MICRONIZED)FENOFIBRATE134MGCAPSULE / ORALAB2002-04-09
A075753-003FENOFIBRATE (MICRONIZED)FENOFIBRATE200MGCAPSULE / ORALAB2002-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075753-001AB
A075753-002AB
A075753-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-002FENOFIBRATE (MICRONIZED)134MGCAPSULE / ORALAB2002-04-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-003FENOFIBRATE (MICRONIZED)200MGCAPSULE / ORALAB2002-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075753-001FENOFIBRATE (MICRONIZED)67MGCAPSULE / ORALAB2002-09-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075753-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075753-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075753-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075753-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075753-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075753-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075753-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075753-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075753-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075753-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075753-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075753-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075753-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075753-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075753-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075753-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075753-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075753-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075753-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075753-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-092-90EA - Each51407-092cabf3ce5-6f3b-4b12-92a2-9a04f0ebd84612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-092FENOFIBRATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Legacy NDC20230420_6e79dd5a-7f8e-53a9-e053-2991aa0a1ecd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-092-905140700929090 CAPSULE in 1 BOTTLE (51407-092-90) 90 capsule2018-06-070000-00-00NoNoCurrent