Ezetimibe

Product NDC: 68788-8297
11-digit product format: 687888297
Labeler code: 68788
Product ID: 68788-8297_462ee7a6-8246-4b04-8465-bb07aae0e739
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA209234
Marketing category: ANDA
Marketing start: 2022-11-29
Marketing end: 0000-00-00
Substance: EZETIMIBE
Active strength: 10 mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
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	68788-8297		D	Discontinued by firm		2026-08-03
excluded package	package	68788-8297	68788-8297-9	D	Discontinued by firm		2026-08-03

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-8297-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-8297-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-8297-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-8297-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-8297-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-8297-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-8297-9	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-8297-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-8297-9	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-8297-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-8297-9	`367a005e9d99…`	`383a685ebd0f…`
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	68788-8297-9	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209234-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209234-001	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	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`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	A209234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209234-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8297-9	EA - Each	68788-8297	a1fc595c-97b1-4821-8aee-9fc0455fac56	1	2023-01-09

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Major Pharmaceuticals	e257ed7f-5015-4f1d-93f4-5adf5797643d	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	American Health Packaging	0e9a9eda-1b2a-4475-8483-0f410a17c524	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	A-S Medication Solutions	dd8a09cb-f014-4650-9da2-4ad1581c9741	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	c92292f5-5444-4247-927e-db7bf6816109	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Ascend Laboratories, LLC	206d702c-b09a-4555-972b-6555d6d6d6e6	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	A-S Medication Solutions	9a04678f-e961-45aa-b3bb-e38e66856edc	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Proficient Rx LP	fbbe54c3-59a1-436c-aba8-188ba7ca70e0	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8297-9	68788829709	90 TABLET in 1 BOTTLE (68788-8297-9)	90 tablet	2022-11-29	0000-00-00	No	No	Current