Gemfibrozil

Product NDC: 16571-784
11-digit product format: 165710784
Labeler code: 16571
Product ID: 16571-784_3e8381a4-86bf-4b7b-8631-ba616a85f3ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202726
Marketing category: ANDA
Marketing start: 2015-09-16
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
A202726-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2015-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202726-001	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 · 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	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202726-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202726-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202726-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202726-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202726-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202726-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202726-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202726-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202726-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202726-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202726-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202726-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202726-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202726-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202726-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202726-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202726-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202726-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202726-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202726-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202726-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202726-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202726-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202726-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202726-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202726-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202726-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202726-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202726-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202726-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202726-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202726-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202726-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202726-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202726-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202726-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202726-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202726-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202726-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202726-001	AB	1	`e64feba35796…`

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
8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	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	Strength	SPL version
16571-784-06	Gemfibrozil	60 in 1 BOTTLE	TABLET, FILM COATED	60		3
16571-784-50	Gemfibrozil	500 in 1 BOTTLE	TABLET, FILM COATED	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-784-06	EA - Each	16571-784	2c5168ac-cb9f-4cab-b971-b21de47c5053	1	2021-12-08
16571-784-50	EA - Each	16571-784	10594327-33e4-4615-b5c0-4f0d42c8df6d	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-784	GEMFIBROZIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240524_8f36abfa-dc52-4c99-8a4a-b0cb80c3249a.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	16d0326a-a55b-448b-be24-a16182aaef5a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	efecc680-f626-46bf-bc2b-3b5a72ba0267	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	Bryant Ranch Prepack	e3ef1638-4c2b-4f74-af31-52c081619963	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	Rising Pharma Holdings, Inc.	8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726 ndc (product): 16571-784
Gemfibrozil	GEMFIBROZIL	Aurobindo Pharma Limited	a68f430e-7c98-4bd9-8902-758706713996	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	NorthStar Rx LLC	b5e33ee2-f766-41d6-8a4b-7b4f0e961bf4	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	NCS HealthCare of KY, LLC dba Vangard Labs	394dfb45-cd3c-4e1e-8dd6-7e4867e90a03	2022-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726

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	e3ef1638-4c2b-4f74-af31-52c081619963	103
310459	gemfibrozil 600 MG Oral Tablet	SCD	e3ef1638-4c2b-4f74-af31-52c081619963	103
310459	gemfibrozil 600 MG Oral Tablet	PSN	8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	3
310459	gemfibrozil 600 MG Oral Tablet	SCD	8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	3
310459	gemfibrozil 600 MG Oral Tablet	PSN	dd700a1d-eab8-4171-b1ad-2c2b05eed1a4	2
310459	gemfibrozil 600 MG Oral Tablet	SCD	dd700a1d-eab8-4171-b1ad-2c2b05eed1a4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-784-06	16571078406	60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06)	2015-09-16	0000-00-00	No	No	Current
16571-784-50	16571078450	500 TABLET, FILM COATED in 1 BOTTLE (16571-784-50)	2015-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP Rx only	Bryant Ranch Prepack	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	103
Gemfibrozil Tablets, USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-05-15	Human Prescription Drug Label	3
Gemfibrozil Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2023-08-10	Human Prescription Drug Label	2