GEMFIBROZIL

Product NDC: 42806-260
11-digit product format: 428060260
Labeler code: 42806
Product ID: 42806-260_e33e6a91-1c1d-4692-b3fb-1ac5776d480b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GEMFIBROZIL
Dosage form: TABLET
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA078012
Marketing category: ANDA
Marketing start: 2017-03-23
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42806-260		I	Inactivated by FDA	2026-08-07
excluded package	package	42806-260	42806-260-05	I	Inactivated by FDA	2026-08-07
excluded package	package	42806-260	42806-260-18	I	Inactivated by FDA	2026-08-07
excluded package	package	42806-260	42806-260-60	I	Inactivated by FDA	2026-08-07

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42806-260-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42806-260-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42806-260-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42806-260-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42806-260-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42806-260-05	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A078012-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078012-001	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	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`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	A078012-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078012-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078012-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078012-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078012-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078012-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078012-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078012-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078012-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078012-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078012-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078012-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078012-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078012-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078012-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078012-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078012-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078012-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078012-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078012-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078012-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078012-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078012-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078012-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078012-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078012-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078012-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078012-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078012-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078012-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078012-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078012-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078012-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078012-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078012-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078012-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078012-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078012-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078012-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078012-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42806-260-05	2025-07-29	C162847	48780-1	3b156c62-2780-fb37-e063-e6dba90a4e07	Gemfibrozil Tablets, USP Rx Only
42806-260-18	2025-07-29	C162847	48780-1	3b156c62-2780-fb37-e063-e6dba90a4e07	Gemfibrozil Tablets, USP Rx Only
42806-260-60	2025-07-29	C162847	48780-1	3b156c62-2780-fb37-e063-e6dba90a4e07	Gemfibrozil Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42806-260-05	GEMFIBROZIL	500 in 1 BOTTLE	TABLET	500	9
42806-260-18	GEMFIBROZIL	180 in 1 BOTTLE	TABLET	180	9
42806-260-60	GEMFIBROZIL	60 in 1 BOTTLE	TABLET	60	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-260-05	EA - Each	42806-260	9b45f163-be15-4533-8925-309d44a72c25	1	2017-04-05
42806-260-60	EA - Each	42806-260	ff661830-e2ed-44d4-9240-058ad1ce0943	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-260	GEMFIBROZIL TABLET [EPIC PHARMA, LLC]	9	Legacy NDC, 3 package rows	20231228_77bb947a-340c-4592-b56d-bc77fb17e753.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	2cb2de4d-8261-46d8-ae63-c572fdc887d4	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078012 application number: ANDA078012
Gemfibrozil	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	17529d33-f24a-1f3f-e063-6394a90ae374	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078012 application number: ANDA078012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	77bb947a-340c-4592-b56d-bc77fb17e753	9
310459	gemfibrozil 600 MG Oral Tablet	SCD	77bb947a-340c-4592-b56d-bc77fb17e753	9
310459	gemfibrozil 600 MG Oral Tablet	PSN	2cb2de4d-8261-46d8-ae63-c572fdc887d4	7
310459	gemfibrozil 600 MG Oral Tablet	SCD	2cb2de4d-8261-46d8-ae63-c572fdc887d4	7
310459	gemfibrozil 600 MG Oral Tablet	PSN	991b0066-ffdc-4ca5-8aa1-15674bcdedd1	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	991b0066-ffdc-4ca5-8aa1-15674bcdedd1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-260-05	42806026005	500 TABLET in 1 BOTTLE (42806-260-05)	500 tablet	2017-03-23	0000-00-00	No	No	Current
42806-260-18	42806026018	180 TABLET in 1 BOTTLE (42806-260-18)	180 tablet	2017-03-23	0000-00-00	No	No	Current
42806-260-60	42806026060	60 TABLET in 1 BOTTLE (42806-260-60)	60 tablet	2017-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP Rx Only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	13
Gemfibrozil Tablets, USP Rx Only	Bryant Ranch Prepack	2024-08-26	HUMAN PRESCRIPTION DRUG LABEL	7
Gemfibrozil Tablets, USP Rx Only	Epic Pharma, LLC \| Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe	2023-12-27	HUMAN PRESCRIPTION DRUG LABEL	9
Gemfibrozil Tablets, USP Rx Only	NuCare Pharmaceuticals,Inc.	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	3
Gemfibrozil Tablets, USP Rx Only	NuCare Pharmaceuticals,Inc.	2019-10-14	HUMAN PRESCRIPTION DRUG LABEL	2
Gemfibrozil Tablets, USP Rx Only	St. Mary's Medical Park Pharmacy \| Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe	2018-11-13	HUMAN PRESCRIPTION DRUG LABEL	3
Gemfibrozil Tablets, USP Rx Only	Preferred Pharmaceuticals Inc.	2017-08-28	HUMAN PRESCRIPTION DRUG LABEL	1