Gemfibrozil

Product NDC: 72578-066
11-digit product format: 725780066
Labeler code: 72578
Product ID: 72578-066_81e93b62-553c-4553-9f0e-44f06293ae7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA204189
Marketing category: ANDA
Marketing start: 2020-02-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204189-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL			2018-08-28

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 · 42 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
2026-08-18 06:07:40	2026-07	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL		2018-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204189-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2018-08-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204189-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204189-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204189-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204189-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204189-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204189-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204189-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204189-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204189-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204189-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204189-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204189-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204189-001	AB	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A204189-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204189-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204189-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMFIBROZIL	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q8X02027X3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2fc2c8fe-6158-4e4d-9753-dc2be1b10f42	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72578-066-01	Gemfibrozil	100 in 1 BOTTLE	TABLET	100	3
72578-066-05	Gemfibrozil	500 in 1 BOTTLE	TABLET	500	3
72578-066-06	Gemfibrozil	30 in 1 BOTTLE	TABLET	30	3
72578-066-10	Gemfibrozil	1000 in 1 BOTTLE	TABLET	1000	3
72578-066-14	Gemfibrozil	60 in 1 BOTTLE	TABLET	60	3
72578-066-16	Gemfibrozil	90 in 1 BOTTLE	TABLET	90	3
72578-066-30	Gemfibrozil	10 in 1 BLISTER PACK	TABLET	10	3
72578-066-77	Gemfibrozil	10 in 1 CARTON	TABLET	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-066-05	EA - Each	72578-066	563598e9-71e1-4fdb-b66d-26324c17c909	1	2022-02-07
72578-066-14	EA - Each	72578-066	56892f93-a354-4d3a-9804-78b3ce5de265	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-066	GEMFIBROZIL TABLET [VIONA PHARMACEUTICALS INC]	3	Current NDC, Legacy NDC, 8 package rows	20231216_2fc2c8fe-6158-4e4d-9753-dc2be1b10f42.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	Zydus Pharmaceuticals (USA) Inc.	556945e8-4100-4538-bcba-af5b2f13a7e8	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204189 application number: ANDA204189
Gemfibrozil	GEMFIBROZIL	Zydus Lifesciences Limited	e6bc1a4f-2a4f-4fdf-8084-488ec8b8b7ab	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204189 application number: ANDA204189
Gemfibrozil	GEMFIBROZIL	Viona Pharmaceuticals Inc	2fc2c8fe-6158-4e4d-9753-dc2be1b10f42	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204189 application number: ANDA204189 ndc (product): 72578-066

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	2fc2c8fe-6158-4e4d-9753-dc2be1b10f42	3
310459	gemfibrozil 600 MG Oral Tablet	SCD	2fc2c8fe-6158-4e4d-9753-dc2be1b10f42	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-066-01	72578006601	100 TABLET in 1 BOTTLE (72578-066-01)	100 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-05	72578006605	500 TABLET in 1 BOTTLE (72578-066-05)	500 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-06	72578006606	30 TABLET in 1 BOTTLE (72578-066-06)	30 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-10	72578006610	1000 TABLET in 1 BOTTLE (72578-066-10)	1000 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-14	72578006614	60 TABLET in 1 BOTTLE (72578-066-14)	60 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-16	72578006616	90 TABLET in 1 BOTTLE (72578-066-16)	90 tablet	2020-02-21	0000-00-00	No	No	Current
72578-066-30	72578006630	10 in 1 BLISTER PACK						Historical
72578-066-77	72578006677	10 BLISTER PACK in 1 CARTON (72578-066-77) / 10 TABLET in 1 BLISTER PACK (72578-066-30)	10 blister pack	2020-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP Rx only	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	3