Gemfibrozil

Product NDC
67046-233
Requested package NDC
67046-233-28
11-digit product format
670460233
Labeler code
67046
Product ID
67046-233_59a0c339-260b-7941-e053-2a91aa0ad5f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077836
Marketing category
ANDA
Marketing start
2017-09-20
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-23367046-233-28IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077836-001GEMFIBROZILGEMFIBROZIL600MGTABLET / ORALAB2006-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077836-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077836-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077836-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077836-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077836-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077836-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077836-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077836-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077836-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077836-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077836-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077836-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077836-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077836-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077836-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077836-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077836-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077836-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077836-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077836-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077836-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077836-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077836-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077836-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077836-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077836-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077836-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077836-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077836-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077836-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077836-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077836-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077836-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077836-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077836-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077836-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077836-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077836-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077836-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077836-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077836-001AB1cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-233-07Gemfibrozil7 in 1 BLISTER PACKTABLET71
67046-233-14Gemfibrozil14 in 1 BLISTER PACKTABLET141
67046-233-15Gemfibrozil15 in 1 BLISTER PACKTABLET151
67046-233-20Gemfibrozil20 in 1 BLISTER PACKTABLET201
67046-233-21Gemfibrozil21 in 1 BLISTER PACKTABLET211
67046-233-28Gemfibrozil28 in 1 BLISTER PACKTABLET281
67046-233-30Gemfibrozil30 in 1 BLISTER PACKTABLET301
67046-233-60Gemfibrozil60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-233GEMFIBROZIL TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170920_59a0c339-260a-7941-e053-2a91aa0ad5f1.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemfibrozilGEMFIBROZILREMEDYREPACK INC.4260d746-bb58-4e10-9ffe-fc414f22b5912026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILCoupler LLC509e6e7c-bb54-f135-e063-6294a90a52792026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILNorthwind Health Company, LLCa95264ab-eb86-7699-e053-2995a90a3d1f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILAmerican Health Packaging4e9e08da-9700-4934-a2b1-4f64c70ea8a22025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILAvPAK3ebb5947-1fe5-9740-6a4b-1f8b577b27112025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILPD-Rx Pharmaceuticals, Inc.5501438d-5247-4f2a-8e15-085276d017252025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILNuCare Pharmaceuticals,Inc.592811f2-e231-6a58-e053-2991aa0a69a92024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILNuCare Pharmaceuticals, Inc.415ac7e0-ddc7-453e-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILProficient Rx LP7dbd38ab-7965-463f-9f8e-70efa8e071fb2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILExelan Pharmaceuticals, Inc.5c09fe54-697e-4cd5-9a26-7c9c7fa9a8642021-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILCipla USA Inc.05bfbcdc-03ab-4fba-9582-980602410ef92021-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLCeb1a2edf-587e-42c5-a98b-58646bc3f9482019-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLC30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe82018-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN59a0c339-260a-7941-e053-2a91aa0ad5f11
310459gemfibrozil 600 MG Oral TabletSCD59a0c339-260a-7941-e053-2a91aa0ad5f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-233-286704602332828 TABLET in 1 BLISTER PACK (67046-233-28) 28 tablet2017-09-200000-00-00NoNoCurrent