GEMFIBROZIL

Product NDC: 72865-186
11-digit product format: 728650186
Labeler code: 72865
Product ID: 72865-186_418dc670-97c2-4103-b924-aed5242e9417
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: XLCare Pharmaceuticals, Inc.
Application: ANDA214603
Marketing category: ANDA
Marketing start: 2021-01-20
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
A214603-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2021-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214603-001	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.

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	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214603-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214603-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214603-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214603-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214603-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214603-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214603-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214603-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214603-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214603-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214603-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214603-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214603-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214603-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214603-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214603-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214603-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214603-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214603-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214603-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214603-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214603-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214603-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214603-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214603-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214603-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214603-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214603-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214603-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214603-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214603-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214603-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214603-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214603-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214603-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214603-001	AB	1	`a50c72e98297…`

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
58c1f50b-9f84-42fe-b7dd-6eece286e28b	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
72865-186-05	GEMFIBROZIL	500 in 1 BOTTLE	TABLET	500	3
72865-186-18	GEMFIBROZIL	180 in 1 BOTTLE	TABLET	180	3
72865-186-60	GEMFIBROZIL	60 in 1 BOTTLE	TABLET	60	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72865-186-05	EA - Each	72865-186	1d9e1947-f01c-4275-ba0d-7883ed81905c	1	2021-05-05
72865-186-18	EA - Each	72865-186	d269f476-a5cb-4317-8100-ce3443e82ee2	1	2021-05-05
72865-186-60	EA - Each	72865-186	68411a88-223e-48cd-b7e9-6f4977741832	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72865-186	GEMFIBROZIL TABLET [XLCARE PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20211008_58c1f50b-9f84-42fe-b7dd-6eece286e28b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMFIBROZIL	GEMFIBROZIL	Preferred Pharmaceuticals, Inc.	2f5738ac-1c9c-4f3a-8c7d-6039d768831e	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	NuCare Pharmaceuticals,Inc.	bfddc3bd-c2dc-449e-e053-2a95a90a8adc	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	1967afce-ce55-4b10-bd8c-e4e94130de87	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	929d6a30-ab06-4b43-9147-ab2cc613b41f	2025-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	REMEDYREPACK INC.	42e40524-57e9-4fee-993f-be0fda14936b	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Proficient Rx LP	e52c9c88-8197-48b4-88cb-1b4b22ceaf16	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	fe98f68c-7182-4a88-93a5-cbdbb37fb8c2	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	54c65a5d-2ff9-493a-90d9-2cff48d1a072	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	7379a1c1-d34f-4eb8-acb8-c5cbaea0f017	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Camber Pharmaceuticals, Inc.	f6a2362a-21e1-442d-9f5d-9e600b5a2ea8	2021-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	XLCare Pharmaceuticals, Inc.	58c1f50b-9f84-42fe-b7dd-6eece286e28b	2021-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 72865-186

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	58c1f50b-9f84-42fe-b7dd-6eece286e28b	3
310459	gemfibrozil 600 MG Oral Tablet	SCD	58c1f50b-9f84-42fe-b7dd-6eece286e28b	3
310459	gemfibrozil 600 MG Oral Tablet	PSN	7379a1c1-d34f-4eb8-acb8-c5cbaea0f017	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	7379a1c1-d34f-4eb8-acb8-c5cbaea0f017	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72865-186-05	72865018605	500 TABLET in 1 BOTTLE (72865-186-05)	500 tablet	2021-01-20	0000-00-00	No	No	Current
72865-186-18	72865018618	180 TABLET in 1 BOTTLE (72865-186-18)	180 tablet	2021-01-20	0000-00-00	No	No	Current
72865-186-60	72865018660	60 TABLET in 1 BOTTLE (72865-186-60)	60 tablet	2021-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemfibrozil Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2021-11-01	HUMAN PRESCRIPTION DRUG LABEL	1
Gemfibrozil Tablets, USP	XLCare Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc.	2021-08-26	HUMAN PRESCRIPTION DRUG LABEL	3