Gemfibrozil

Product NDC
66267-436
11-digit product format
662670436
Labeler code
66267
Product ID
66267-436_1fa6f6ca-cf67-49fd-e063-6394a90a73f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA077836
Marketing category
ANDA
Marketing start
2016-07-08
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-436-92557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-436-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-436-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-436-928af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-436-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-436-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-436-92834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-436-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-436-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-436-921332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-436-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-436-301332a3947898…d4bfe170f9cd…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMFIBROZIL600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q8X02027X3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415ac7e0-ddc7-453e-e054-00144ff8d46cAvailable on FDA.report

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
66267-436-30Gemfibrozil30 in 1 BOTTLETABLET305
66267-436-60Gemfibrozil60 in 1 BOTTLETABLET605
66267-436-92Gemfibrozil180 in 1 BOTTLETABLET1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-436-30EA - Each66267-43610ee6d2c-1708-4e87-9094-e7d7302e741312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-436GEMFIBROZIL TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240815_415ac7e0-ddc7-453e-e054-00144ff8d46c.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
ndc (product): 66267-436
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 TabletPSN415ac7e0-ddc7-453e-e054-00144ff8d46c5
310459gemfibrozil 600 MG Oral TabletSCD415ac7e0-ddc7-453e-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-436-306626704363030 TABLET in 1 BOTTLE (66267-436-30) 30 tablet2016-11-150000-00-00NoNoCurrent
66267-436-606626704366060 TABLET in 1 BOTTLE (66267-436-60) 60 tablet2016-11-150000-00-00NoNoCurrent
66267-436-9266267043692180 TABLET in 1 BOTTLE (66267-436-92) 180 tablet2016-11-150000-00-00NoNoCurrent