Gemfibrozil

Product NDC: 69097-821
11-digit product format: 690970821
Labeler code: 69097
Product ID: 69097-821_2d16c495-7862-4ffc-a9ee-a1c816af5ae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA077836
Marketing category: ANDA
Marketing start: 2016-10-13
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 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…`

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
05bfbcdc-03ab-4fba-9582-980602410ef9	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
69097-821-03	Gemfibrozil	60 in 1 BOTTLE	TABLET	60	8
69097-821-07	Gemfibrozil	100 in 1 BOTTLE	TABLET	100	8
69097-821-12	Gemfibrozil	500 in 1 BOTTLE	TABLET	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-821-03	EA - Each	69097-821	6f0adea9-bb5b-4a29-9b37-53e159fdd8d6	1	2016-07-19
69097-821-12	EA - Each	69097-821	8cfe292f-fdaa-4ed8-84b2-06c921512a70	1	2016-07-19

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-821	GEMFIBROZIL TABLET [CIPLA USA INC.]	8	Current NDC, Legacy NDC, 3 package rows	20210622_05bfbcdc-03ab-4fba-9582-980602410ef9.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 ndc (product): 69097-821
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	4260d746-bb58-4e10-9ffe-fc414f22b591	21
310459	gemfibrozil 600 MG Oral Tablet	SCD	4260d746-bb58-4e10-9ffe-fc414f22b591	21
310459	gemfibrozil 600 MG Oral Tablet	PSN	5501438d-5247-4f2a-8e15-085276d01725	18
310459	gemfibrozil 600 MG Oral Tablet	SCD	5501438d-5247-4f2a-8e15-085276d01725	18
310459	gemfibrozil 600 MG Oral Tablet	PSN	3ebb5947-1fe5-9740-6a4b-1f8b577b2711	11
310459	gemfibrozil 600 MG Oral Tablet	SCD	3ebb5947-1fe5-9740-6a4b-1f8b577b2711	11
310459	gemfibrozil 600 MG Oral Tablet	PSN	4e9e08da-9700-4934-a2b1-4f64c70ea8a2	9
310459	gemfibrozil 600 MG Oral Tablet	SCD	4e9e08da-9700-4934-a2b1-4f64c70ea8a2	9
310459	gemfibrozil 600 MG Oral Tablet	PSN	05bfbcdc-03ab-4fba-9582-980602410ef9	8
310459	gemfibrozil 600 MG Oral Tablet	SCD	05bfbcdc-03ab-4fba-9582-980602410ef9	8
310459	gemfibrozil 600 MG Oral Tablet	PSN	415ac7e0-ddc7-453e-e054-00144ff8d46c	5
310459	gemfibrozil 600 MG Oral Tablet	PSN	07e298e2-c324-4524-a4f6-4d1162d78376	5
310459	gemfibrozil 600 MG Oral Tablet	PSN	592811f2-e231-6a58-e053-2991aa0a69a9	5
310459	gemfibrozil 600 MG Oral Tablet	PSN	7dbd38ab-7965-463f-9f8e-70efa8e071fb	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	415ac7e0-ddc7-453e-e054-00144ff8d46c	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	07e298e2-c324-4524-a4f6-4d1162d78376	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	592811f2-e231-6a58-e053-2991aa0a69a9	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	7dbd38ab-7965-463f-9f8e-70efa8e071fb	5
310459	gemfibrozil 600 MG Oral Tablet	PSN	a95264ab-eb86-7699-e053-2995a90a3d1f	4
310459	gemfibrozil 600 MG Oral Tablet	PSN	8f9cce0a-1073-3c21-e053-2a95a90a8b87	4
310459	gemfibrozil 600 MG Oral Tablet	SCD	a95264ab-eb86-7699-e053-2995a90a3d1f	4
310459	gemfibrozil 600 MG Oral Tablet	SCD	8f9cce0a-1073-3c21-e053-2a95a90a8b87	4
310459	gemfibrozil 600 MG Oral Tablet	PSN	eb1a2edf-587e-42c5-a98b-58646bc3f948	2
310459	gemfibrozil 600 MG Oral Tablet	SCD	eb1a2edf-587e-42c5-a98b-58646bc3f948	2
310459	gemfibrozil 600 MG Oral Tablet	PSN	5c87947c-42a1-f79e-e053-2a91aa0a8e01	1
310459	gemfibrozil 600 MG Oral Tablet	PSN	59a0c339-260a-7941-e053-2a91aa0ad5f1	1
310459	gemfibrozil 600 MG Oral Tablet	PSN	509e6e7c-bb54-f135-e063-6294a90a5279	1
310459	gemfibrozil 600 MG Oral Tablet	PSN	2e46fee5-d646-43a2-8737-8b09094043e3	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	5c87947c-42a1-f79e-e053-2a91aa0a8e01	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	59a0c339-260a-7941-e053-2a91aa0ad5f1	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	509e6e7c-bb54-f135-e063-6294a90a5279	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	2e46fee5-d646-43a2-8737-8b09094043e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-821-03	69097082103	60 TABLET in 1 BOTTLE (69097-821-03)	60 tablet	2016-10-13	0000-00-00	No	No	Current
69097-821-07	69097082107	100 TABLET in 1 BOTTLE (69097-821-07)	100 tablet	2016-10-13	0000-00-00	No	No	Current
69097-821-12	69097082112	500 TABLET in 1 BOTTLE (69097-821-12)	500 tablet	2016-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP 600 mg	REMEDYREPACK INC.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	22
Gemfibrozil Tablets, USP 600 mg	Coupler LLC \| Cipla USA Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	1
Gemfibrozil Tablets, USP 600 mg	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Gemfibrozil Tablets, USP 8422401/1223 Rx only	American Health Packaging	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	9
Gemfibrozil Tablets, USP Rx Only	AvPAK	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	11
Gemfibrozil Tablets, USP 600 mg	PD-Rx Pharmaceuticals, Inc.	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	18
Gemfibrozil Tablets, USP 600 mg	Preferred Pharmaceuticals Inc.	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	11
Gemfibrozil Tablets, USP 600 mg	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	5
Gemfibrozil Tablets, 600 mg	NuCare Pharmaceuticals, Inc. \| NuCare Pharmaceutical, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
Gemfibrozil Tablets, USP 600 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Gemfibrozil Tablets, USP 600 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
GEMFIBROZIL	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	4
Gemfibrozil Tablets, 600 mg	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Gemfibrozil Tablets, USP 600 mg	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	6
Gemfibrozil Tablets, USP 600 mg	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2021-06-18	HUMAN PRESCRIPTION DRUG LABEL	8
Gemfibrozil Tablets, USP 600 mg	A-S Medication Solutions	2021-03-08	HUMAN PRESCRIPTION DRUG LABEL	11
Gemfibrozil Tablets, USP 600 mg	Lake Erie Medical DBA Quality Care Products LLC	2020-11-03	HUMAN PRESCRIPTION DRUG LABEL	5
Gemfibrozil Tablets, USP 600 mg	REMEDYREPACK INC.	2020-05-19	HUMAN PRESCRIPTION DRUG LABEL	4
Gemfibrozil Tablets, USP 600 mg	Aphena Pharma Solutions - Tennessee, LLC	2019-01-08	HUMAN PRESCRIPTION DRUG LABEL	2
Gemfibrozil Tablets, 600 mg	KAISER FOUNDATION HOSPITALS	2018-11-28	HUMAN PRESCRIPTION DRUG LABEL	2
GEMFIBROZIL 600mg	direct rx	2017-10-27	HUMAN PRESCRIPTION DRUG LABEL	1
Gemfibrozil Tablets, USP 600 mg 233	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-20	HUMAN PRESCRIPTION DRUG LABEL	1