GEMFIBROZIL

Product NDC: 43063-921
11-digit product format: 430630921
Labeler code: 43063
Product ID: 43063-921_e6da3695-c869-ebac-e053-2a95a90a7df4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GEMFIBROZIL
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43063-921		D	Discontinued by firm		2026-08-10
excluded package	package	43063-921	43063-921-60	D	Discontinued by firm		2026-08-10

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
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-921-60	EA - Each	43063-921	5ad64c88-7e53-44ac-83bc-22f56f8bc24a	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-921	GEMFIBROZIL TABLET [PD-RX PHARMACEUTICALS, INC.]	12	Legacy NDC	20240704_fd7c7a13-4d2a-4b98-8e1d-a1a99c3657e9.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-921-60	43063092160	60 TABLET in 1 BOTTLE, PLASTIC (43063-921-60)	60 tablet	2018-12-26	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