Zetia

Product NDC: 66582-414
11-digit product format: 665820414
Labeler code: 66582
Product ID: 66582-414_23251c26-8006-45df-b44d-c49c5882377b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA021445
Marketing category: NDA
Marketing start: 2002-10-25
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: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66582-414		D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-15	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-28	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-30	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-31	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-54	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-74	D	Discontinued by firm	2026-08-03
excluded package	package	66582-414	66582-414-76	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 2 · 96 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	66582-414-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66582-414-54	`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	66582-414-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66582-414-54	`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	66582-414-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-74	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-76	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66582-414-54	`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	66582-414-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-74	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-76	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66582-414-54	`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	66582-414-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-74	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-76	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66582-414-54	`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	66582-414-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-74	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-76	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66582-414-54	`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	66582-414-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-74	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-76	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66582-414-54	`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	66582-414-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66582-414-74	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66582-414-28	`ed331223b511…`	`672a5bd82f5f…`

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
N021445-001	ZETIA	EZETIMIBE	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021445-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N021445-001	7612058	2025-10-30	U-1027
N021445-001	7612058	2025-10-30	U-1173
N021445-001	7612058*PED	2026-04-30		Pediatric extension

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021445-001	ZETIA	10MG	TABLET / ORAL	AB	RLD, RS	2002-10-25	`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	N021445-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021445-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021445-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021445-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021445-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021445-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021445-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021445-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021445-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021445-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021445-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021445-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021445-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021445-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021445-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021445-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021445-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021445-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021445-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021445-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021445-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021445-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021445-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021445-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021445-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021445-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021445-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021445-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021445-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021445-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021445-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021445-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021445-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021445-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021445-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021445-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021445-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021445-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021445-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021445-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021445-001	7612058	2025-10-30	U-1173		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021445-001	7612058	2025-10-30	U-1027		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021445-001	7612058	2025-10-30	U-1173		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021445-001	7612058	2025-10-30	U-1027		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021445-001	7612058	2025-10-30	U-1173		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021445-001	7612058	2025-10-30	U-1027		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021445-001	7612058	2025-10-30	U-1173		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021445-001	7612058	2025-10-30	U-1027		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021445-001	7612058	2025-10-30	U-1173		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021445-001	7612058	2025-10-30	U-1027		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021445-001	7612058	2025-10-30	U-1173		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021445-001	7612058	2025-10-30	U-1027		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021445-001	7612058	2025-10-30	U-1173		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021445-001	7612058	2025-10-30	U-1027		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021445-001	7612058	2025-10-30	U-1173		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021445-001	7612058	2025-10-30	U-1027		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021445-001	7612058	2025-10-30	U-1173		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021445-001	7612058	2025-10-30	U-1027		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021445-001	7612058	2025-10-30	U-1173		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021445-001	7612058	2025-10-30	U-1027		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021445-001	7612058	2025-10-30	U-1173		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021445-001	7612058	2025-10-30	U-1027		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021445-001	7612058	2025-10-30	U-1173		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021445-001	7612058	2025-10-30	U-1027		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021445-001	7612058	2025-10-30	U-1173		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021445-001	7612058	2025-10-30	U-1027		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021445-001	7612058*PED	2026-04-30		Pediatric extension	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021445-001	7612058	2025-10-30	U-1173		`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
93a156a6-903b-1690-4dc3-a57adfaa8c1a	Product name	9	20230322
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
b249faa8-b784-47ef-8ad4-031ef248fa73	Product name	1	20200626
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66582-414-28	EA - Each	66582-414	02be090e-310a-4068-aeba-079861d852a6	1	2012-07-24
66582-414-29	EA - Each	66582-414	4969a4a4-5e7a-49b5-b04c-23014634669a	1	2012-07-24
66582-414-31	EA - Each	66582-414	d437f409-76f1-40ab-808b-2b1867b0298f	1	2012-07-24
66582-414-54	EA - Each	66582-414	7fc6a5eb-11ef-45fd-8c41-b4aeb8c52f0a	1	2012-07-24
66582-414-74	EA - Each	66582-414	3df3bfa0-7c3c-4aa4-8b9d-ba4e344883aa	1	2012-07-24
66582-414-76	EA - Each	66582-414	4aaeba6b-d447-48d9-bafd-621817013e37	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
Ezetimibe	ACTIVE MOIETY	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
povidones	INACTIVE INGREDIENT	FZ989GH94E	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.]	14
EZETIMIBE	ACTIVE INGREDIENT	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
Ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
EZETIMIBE	ACTIVE MOIETY	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
Ezetimibe	ACTIVE MOIETY	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZETIA (EZETIMIBE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ZETIA (EZETIMIBE) TABLET [CARDINAL HEALTH]	2
Ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
Ezetimibe	ACTIVE MOIETY	EOR26LQQ24	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zetia	EZETIMIBE	Organon LLC	174e45e0-45bb-48b7-9e60-8f6cfc1d22bb	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021445 application number: NDA021445

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349556	ezetimibe 10 MG Oral Tablet	PSN	cb18564f-663f-4da2-9dd9-700ea9bdd398	2
352304	Zetia 10 MG Oral Tablet	PSN	cb18564f-663f-4da2-9dd9-700ea9bdd398	2
352304	ezetimibe 10 MG Oral Tablet [Zetia]	SBD	cb18564f-663f-4da2-9dd9-700ea9bdd398	2
349556	ezetimibe 10 MG Oral Tablet	SCD	cb18564f-663f-4da2-9dd9-700ea9bdd398	2
352304	Zetia 10 MG Oral Tablet	SY	cb18564f-663f-4da2-9dd9-700ea9bdd398	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66582-414-15	66582041415	7 TABLET in 1 BLISTER PACK (66582-414-15)	7 tablet	2002-10-25	0000-00-00	No	No	Current
66582-414-28	66582041428	100 BLISTER PACK in 1 CARTON (66582-414-28) > 1 TABLET in 1 BLISTER PACK (66582-414-29)	100 blister pack	2002-10-25	0000-00-00	No	No	Current
66582-414-30	66582041430	30 TABLET in 1 BOTTLE (66582-414-30)	30 tablet	2002-10-25	0000-00-00	No	No	Current
66582-414-31	66582041431	30 TABLET in 1 BOTTLE (66582-414-31)	30 tablet	2002-10-25	0000-00-00	No	No	Current
66582-414-54	66582041454	90 TABLET in 1 BOTTLE (66582-414-54)	90 tablet	2002-10-25	0000-00-00	No	No	Current
66582-414-74	66582041474	500 TABLET in 1 BOTTLE (66582-414-74)	500 tablet	2002-10-25	0000-00-00	No	No	Current
66582-414-76	66582041476	5000 TABLET in 1 BOTTLE (66582-414-76)	5000 tablet	2002-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zetia	Merck Sharp & Dohme Corp.	2021-10-19	HUMAN PRESCRIPTION DRUG LABEL	23
Zetia	A-S Medication Solutions	2017-10-26	HUMAN PRESCRIPTION DRUG LABEL	2
Zetia	Cardinal Health	2015-05-07	HUMAN PRESCRIPTION DRUG LABEL	2
Zetia	Physicians Total Care, Inc.	2009-12-29	HUMAN PRESCRIPTION DRUG LABEL	2