Gemfibrozil

Product NDC: 71335-0971
11-digit product format: 713350971
Labeler code: 71335
Product ID: 71335-0971_52a2582f-0237-4d41-9496-f222ed522e1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA079072
Marketing category: ANDA
Marketing start: 2010-12-20
Marketing end: 2026-06-30
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
Current FDA listing: Yes

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0971		D	Discontinued by firm	2026-08-07
excluded package	package	71335-0971	71335-0971-1	D	Discontinued by firm	2026-08-07
excluded package	package	71335-0971	71335-0971-2	D	Discontinued by firm	2026-08-07
excluded package	package	71335-0971	71335-0971-3	D	Discontinued by firm	2026-08-07
excluded package	package	71335-0971	71335-0971-4	D	Discontinued by firm	2026-08-07
excluded package	package	71335-0971	71335-0971-5	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 · 24 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
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	71335-0971-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0971-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0971-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0971-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0971-5	`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	71335-0971-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0971-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0971-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0971-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0971-5	`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	71335-0971-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0971-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0971-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0971-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0971-5	`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	71335-0971-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0971-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0971-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0971-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0971-5	`1332a3947898…`	`d4bfe170f9cd…`

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
A079072-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2010-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079072-001	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	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`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	A079072-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	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, Related label table
NDC	Effective	Related label
71335-0971-1	2024-09-11	Rx Only
71335-0971-2	2024-09-11	Rx Only
71335-0971-3	2024-09-11	Rx Only
71335-0971-4	2024-09-11	Rx Only
71335-0971-5	2024-09-11	Rx Only
71335-0971-1	2024-01-30	Rx Only
71335-0971-2	2024-01-30	Rx Only
71335-0971-3	2024-01-30	Rx Only
71335-0971-4	2024-01-30	Rx Only
71335-0971-5	2024-01-30	Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0971-1	Gemfibrozil	60 in 1 BOTTLE	TABLET	60	5
71335-0971-2	Gemfibrozil	30 in 1 BOTTLE	TABLET	30	5
71335-0971-3	Gemfibrozil	100 in 1 BOTTLE	TABLET	100	5
71335-0971-4	Gemfibrozil	90 in 1 BOTTLE	TABLET	90	5
71335-0971-5	Gemfibrozil	180 in 1 BOTTLE	TABLET	180	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0971	GEMFIBROZIL TABLET [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 5 package rows	20240913_325afd72-9176-4a08-8383-58cecb35196d.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	Northstar RxLLC	75cac02c-56e3-4dfe-b1e2-4ce166b28833	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	5738f713-d4b4-437c-b931-fb3b2c22f6d3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	4907bbfa-27f4-4569-8957-9704f9c998a0	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072

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	325afd72-9176-4a08-8383-58cecb35196d	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	325afd72-9176-4a08-8383-58cecb35196d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0971-1	71335097101	60 TABLET in 1 BOTTLE (71335-0971-1)	60 tablet	2018-10-22	2026-06-30	No	No	Current
71335-0971-2	71335097102	30 TABLET in 1 BOTTLE (71335-0971-2)	30 tablet	2018-11-09	2026-06-30	No	No	Current
71335-0971-3	71335097103	100 TABLET in 1 BOTTLE (71335-0971-3)	100 tablet	2024-09-05	2026-06-30	No	No	Current
71335-0971-4	71335097104	90 TABLET in 1 BOTTLE (71335-0971-4)	90 tablet	2024-09-05	2026-06-30	No	No	Current
71335-0971-5	71335097105	180 TABLET in 1 BOTTLE (71335-0971-5)	180 tablet	2024-09-05	2026-06-30	No	No	Current