Gemfibrozil

Product NDC: 63187-146
11-digit product format: 631870146
Labeler code: 63187
Product ID: 63187-146_e9f3d596-be8b-47ed-9982-5c26878e3def
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077836
Marketing category: ANDA
Marketing start: 2011-01-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-146		D	Discontinued by firm	2026-08-07
excluded package	package	63187-146	63187-146-30	D	Discontinued by firm	2026-08-07
excluded package	package	63187-146	63187-146-78	D	Discontinued by firm	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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-146-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-146-78	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-146-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-146-78	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-146-78	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-146-30	E	Excluded after deficient or non-compliant submission was not corrected	`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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GEMFIBROZIL	ACTIVE INGREDIENT	Q8X02027X3	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
GEMFIBROZIL	ACTIVE MOIETY	Q8X02027X3	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
METHYLCELLULOSE (15 MPA.S)	INACTIVE INGREDIENT	NPU9M2E6L8	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GEMFIBROZIL TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-146	GEMFIBROZIL TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191212_2b916bf7-1c69-412a-8dab-40294d34df2d.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
63187-146-30	63187014630	30 TABLET in 1 BOTTLE (63187-146-30)	30 tablet	2014-08-01	0000-00-00	No	No	Current
63187-146-78	63187014678	180 TABLET in 1 BOTTLE (63187-146-78)	180 tablet	2014-08-01	0000-00-00	No	No	Current