Zetia

Product NDC: 50090-0833
11-digit product format: 500900833
Labeler code: 50090
Product ID: 50090-0833_dbdc73a2-c144-4fd0-a4af-d821ff0617f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
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: 2019-12-31
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	50090-0833		D	Discontinued by firm		2026-08-03
excluded package	package	50090-0833	50090-0833-0	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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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	50090-0833-0	`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
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…`

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