Gemfibrozil

Product NDC
57237-163
11-digit product format
572370163
Labeler code
57237
Product ID
57237-163_1a6818d9-bb45-482b-bac6-9cd32027ae3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Health, LLC
Application
ANDA202726
Marketing category
ANDA
Marketing start
2015-09-16
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57237-163DDiscontinued by firm2026-08-17
excluded packagepackage57237-16357237-163-05DDiscontinued by firm2026-08-17
excluded packagepackage57237-16357237-163-60DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage57237-163-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57237-163-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57237-163-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57237-163-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57237-163-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57237-163-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57237-163-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57237-163-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57237-163-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57237-163-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57237-163-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57237-163-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57237-163-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57237-163-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57237-163-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57237-163-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57237-163-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57237-163-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57237-163-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57237-163-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57237-163-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57237-163-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57237-163-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57237-163-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202726-001GEMFIBROZILGEMFIBROZIL600MGTABLET / ORALAB2015-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202726-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202726-001GEMFIBROZIL600MGTABLET / ORALAB2015-09-16e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202726-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202726-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202726-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202726-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202726-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202726-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202726-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202726-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202726-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202726-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202726-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202726-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202726-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202726-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202726-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202726-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202726-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202726-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202726-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202726-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202726-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202726-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202726-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202726-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202726-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202726-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202726-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202726-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202726-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202726-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202726-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202726-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202726-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202726-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202726-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202726-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202726-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202726-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202726-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202726-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-163-05EA - Each57237-163b3f6f560-7583-44b1-b1f8-41e4c7bf0c3412016-04-04
57237-163-60EA - Each57237-163c679cfd7-170b-4271-bc67-ba1feb294c3c12016-04-04

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemfibrozilGEMFIBROZILA-S Medication Solutions16d0326a-a55b-448b-be24-a16182aaef5a2024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILA-S Medication Solutionsefecc680-f626-46bf-bc2b-3b5a72ba02672024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILBryant Ranch Prepacke3ef1638-4c2b-4f74-af31-52c0816199632024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILRising Pharma Holdings, Inc.8f36abfa-dc52-4c99-8a4a-b0cb80c3249a2024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILAurobindo Pharma Limiteda68f430e-7c98-4bd9-8902-7587067139962024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILNorthStar Rx LLCb5e33ee2-f766-41d6-8a4b-7b4f0e961bf42024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726
GemfibrozilGEMFIBROZILNCS HealthCare of KY, LLC dba Vangard Labs394dfb45-cd3c-4e1e-8dd6-7e4867e90a032022-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202726
application number: ANDA202726

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNf20eb470-a6db-40c2-9113-8023eb0ea4d25
310459gemfibrozil 600 MG Oral TabletSCDf20eb470-a6db-40c2-9113-8023eb0ea4d25
310459gemfibrozil 600 MG Oral TabletPSN4532f5fd-0396-481e-b827-fbf12e0252314
310459gemfibrozil 600 MG Oral TabletSCD4532f5fd-0396-481e-b827-fbf12e0252314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-163-0557237016305500 TABLET, FILM COATED in 1 BOTTLE (57237-163-05) 2015-09-160000-00-00NoNoCurrent
57237-163-605723701636060 TABLET, FILM COATED in 1 BOTTLE (57237-163-60) 2015-09-160000-00-00NoNoCurrent