Gemfibrozil

Product NDC: 51138-588
11-digit product format: 511380588
Labeler code: 51138
Product ID: 51138-588_fdf6ae68-5234-4aac-ab0d-38fa7e87f7a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Med-Health Pharma, LLC
Application: ANDA077836
Marketing category: ANDA
Marketing start: 2011-07-04
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51138-588		I	Inactivated by FDA		2026-08-03
excluded package	package	51138-588	51138-588-30	I	Inactivated by FDA		2026-08-03

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 · 44 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	51138-588-30	`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	51138-588-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51138-588-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51138-588-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51138-588-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51138-588-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51138-588-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51138-588-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51138-588-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51138-588-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51138-588-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51138-588-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51138-588-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51138-588-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51138-588-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51138-588-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51138-588-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51138-588-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51138-588-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51138-588-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51138-588-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51138-588-30	`110d247fa046…`	`a55b01930146…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51138-588-30	2019-11-13	C162847	48780-1	97449f38-d028-f6ea-e053-dbdaa90aa703	Gemfibrozil Tablets, USP Rev. 12/10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51138-588-30	Gemfibrozil	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GEMFIBROZIL	ACTIVE INGREDIENT	Q8X02027X3	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
GEMFIBROZIL	ACTIVE MOIETY	Q8X02027X3	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
METHYLCELLULOSE (1500 MPA.S)	INACTIVE INGREDIENT	P0NTE48364	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51138-588	GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]	3	Legacy NDC, 1 package rows	20120216_b57eeb99-679e-4136-80f4-85421e21400b.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	b57eeb99-679e-4136-80f4-85421e21400b	3
310459	gemfibrozil 600 MG Oral Tablet	SCD	b57eeb99-679e-4136-80f4-85421e21400b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51138-588-30	51138058830	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP Rev. 12/10	Med-Health Pharma, LLC	2011-07-04	HUMAN PRESCRIPTION DRUG LABEL	3