Gemfibrozil

Product NDC: 68788-6447
11-digit product format: 687886447
Labeler code: 68788
Product ID: 68788-6447_a0ea12b0-6ed4-40f9-b716-570a827bd5c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA077836
Marketing category: ANDA
Marketing start: 2016-08-02
Marketing end: 0000-00-00
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: 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-6447		D	Discontinued by firm	2026-08-03
excluded package	package	68788-6447	68788-6447-3	D	Discontinued by firm	2026-08-03
excluded package	package	68788-6447	68788-6447-6	D	Discontinued by firm	2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077836-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2006-07-27

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077836-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2006-07-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077836-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077836-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077836-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077836-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077836-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077836-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077836-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077836-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077836-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077836-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077836-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077836-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077836-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077836-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077836-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077836-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077836-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077836-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077836-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077836-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077836-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077836-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077836-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077836-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077836-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077836-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077836-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077836-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077836-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077836-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077836-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077836-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077836-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077836-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077836-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077836-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077836-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077836-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077836-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077836-001	AB	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6447	GEMFIBROZIL TABLET [PREFERRED PHARMACEUTICALS INC.]	10	Legacy NDC	20240509_196f706b-7234-4c53-ada2-93c4df02f178.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	REMEDYREPACK INC.	4260d746-bb58-4e10-9ffe-fc414f22b591	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Coupler LLC	509e6e7c-bb54-f135-e063-6294a90a5279	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Northwind Health Company, LLC	a95264ab-eb86-7699-e053-2995a90a3d1f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	American Health Packaging	4e9e08da-9700-4934-a2b1-4f64c70ea8a2	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	AvPAK	3ebb5947-1fe5-9740-6a4b-1f8b577b2711	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	5501438d-5247-4f2a-8e15-085276d01725	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	NuCare Pharmaceuticals,Inc.	592811f2-e231-6a58-e053-2991aa0a69a9	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	NuCare Pharmaceuticals, Inc.	415ac7e0-ddc7-453e-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Proficient Rx LP	7dbd38ab-7965-463f-9f8e-70efa8e071fb	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Exelan Pharmaceuticals, Inc.	5c09fe54-697e-4cd5-9a26-7c9c7fa9a864	2021-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Cipla USA Inc.	05bfbcdc-03ab-4fba-9582-980602410ef9	2021-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	eb1a2edf-587e-42c5-a98b-58646bc3f948	2019-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836
Gemfibrozil	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe8	2018-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077836 application number: ANDA077836

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q8X02027X3	GEMFIBROZIL	25812-30-0	GEMFIBROZIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-6447-3	68788644703	30 TABLET in 1 BOTTLE (68788-6447-3)	30 tablet	2016-08-02	0000-00-00	No	No	Current
68788-6447-6	68788644706	60 TABLET in 1 BOTTLE (68788-6447-6)	60 tablet	2016-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP 600 mg	Preferred Pharmaceuticals Inc.	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	11