Fenofibric Acid

Product NDC
70436-169
11-digit product format
704360169
Labeler code
70436
Product ID
70436-169_ed7e4b4a-fe0e-5f1c-e053-2995a90a6c8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA212562
Marketing category
ANDA
Marketing start
2022-04-11
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
135 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70436-169DDiscontinued by firm2026-10-05
excluded packagepackage70436-16970436-169-02DDiscontinued by firm2026-10-05
excluded packagepackage70436-16970436-169-06DDiscontinued by firm2026-10-05

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70436-169-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70436-169-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70436-169-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70436-169-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70436-169-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70436-169-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70436-169-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70436-169-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70436-169-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70436-169-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70436-169-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70436-169-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70436-169-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70436-169-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70436-169-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70436-169-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70436-169-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70436-169-020efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212562-001FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23
A212562-002FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212562-001AB
A212562-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2384e616aacf4f…
2026-09-14 22:38:342026-08A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2384e616aacf4f…
2026-08-18 06:07:402026-07A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212562-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212562-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2020-12-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212562-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212562-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212562-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212562-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212562-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212562-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212562-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212562-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212562-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212562-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212562-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212562-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212562-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212562-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212562-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212562-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212562-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212562-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212562-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212562-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212562-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212562-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212562-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212562-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212562-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212562-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212562-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212562-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212562-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212562-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212562-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212562-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212562-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212562-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212562-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212562-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212562-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212562-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212562-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212562-002AB1bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-169-06EA - Each70436-16997ffe088-c676-4fcc-a6bb-f7589636300712022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-169-0370436016903500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-169-03) 2021-06-150000-00-00NoNoCurrent
70436-169-067043601690690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-169-06) 2021-06-150000-00-00NoNoCurrent