Zetia

Product NDC: 21695-778
11-digit product format: 216950778
Labeler code: 21695
Product ID: 21695-778_582e1593-1e6c-4ce8-8bae-134fbc3a66f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021445
Marketing category: NDA
Marketing start: 2009-07-27
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-778		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-778	21695-778-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-778	21695-778-90	I	Inactivated by FDA	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 · 66 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	21695-778-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-778-90	`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	21695-778-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-778-90	`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	21695-778-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-778-90	`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	21695-778-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-778-90	`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	21695-778-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-778-90	`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	21695-778-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-778-90	`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	21695-778-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-778-90	`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	21695-778-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-778-90	`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	21695-778-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-778-90	`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	21695-778-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-778-90	`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	21695-778-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-778-90	`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	21695-778-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-778-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-778-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-778-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-778-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-778-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-778-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-778-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-778-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-778-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-778-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-778-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-778-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-778-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-778-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-778-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-778-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-778-90	`e2bbac7714bc…`	`27bdfed8d636…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-778-30	2019-09-24	C162847	48780-1	934fe258-4a88-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) Tablets Initial U.S. Approval: 2002
21695-778-90	2019-09-24	C162847	48780-1	934fe258-4a88-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) Tablets Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-778-30	Zetia	30 in 1 BOTTLE	TABLET	30		1
21695-778-90	Zetia	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-778-30	EA - Each	21695-778	76f7d438-8298-43ea-ad1f-63cc5995fd53	1	2012-07-24
21695-778-90	EA - Each	21695-778	2d950d7c-0ea3-469a-82df-b253e6e9502e	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 [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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-778	ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110622_582e1593-1e6c-4ce8-8bae-134fbc3a66f0.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 · 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	582e1593-1e6c-4ce8-8bae-134fbc3a66f0	1
352304	Zetia 10 MG Oral Tablet	PSN	582e1593-1e6c-4ce8-8bae-134fbc3a66f0	1
352304	ezetimibe 10 MG Oral Tablet [Zetia]	SBD	582e1593-1e6c-4ce8-8bae-134fbc3a66f0	1
349556	ezetimibe 10 MG Oral Tablet	SCD	582e1593-1e6c-4ce8-8bae-134fbc3a66f0	1
352304	Zetia 10 MG Oral Tablet	SY	582e1593-1e6c-4ce8-8bae-134fbc3a66f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-778-30	21695077830	30 in 1 BOTTLE	Historical
21695-778-90	21695077890	90 in 1 BOTTLE	Historical