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

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 Identifiers#

Field, Values table
Field	Values
Unii	Q8X02027X3
Rxcui	310459

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

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.	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	21
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	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	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	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2021-06-18	HUMAN PRESCRIPTION DRUG LABEL	8
Gemfibrozil Tablets, USP 600 mg	Aphena Pharma Solutions - Tennessee, LLC	2019-01-08	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
Gemfibrozil Tablets, 600 mg	Aidarex Pharmaceuticals LLC	2016-12-06	HUMAN PRESCRIPTION DRUG LABEL	1

Gemfibrozil

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#