EZETIMIBE

Product NDC: 16729-433
11-digit product format: 167290433
Labeler code: 16729
Product ID: 16729-433_411f7e5b-cb87-22d4-e063-6394a90a518c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EZETIMIBE
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA211550
Marketing category: ANDA
Marketing start: 2019-10-07
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: 2026-12-31
Current FDA listing: Yes

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 package	package	16729-433	16729-433-15	D	Discontinued by firm		2026-08-03
excluded package	package	16729-433	16729-433-16	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 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	16729-433-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	16729-433-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	16729-433-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	16729-433-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	16729-433-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	16729-433-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	16729-433-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	16729-433-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	16729-433-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	16729-433-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	16729-433-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	16729-433-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	16729-433-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	16729-433-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	16729-433-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	16729-433-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	16729-433-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	16729-433-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	16729-433-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	16729-433-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	16729-433-15	`367a005e9d99…`	`383a685ebd0f…`

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
A211550-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211550-001	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	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL		2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211550-001	EZETIMIBE	10MG	TABLET / ORAL		2018-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211550-001	EZETIMIBE	10MG	TABLET / ORAL		2018-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211550-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2018-10-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211550-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211550-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211550-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211550-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211550-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211550-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211550-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211550-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211550-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211550-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211550-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211550-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211550-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211550-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211550-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211550-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211550-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211550-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211550-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211550-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211550-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211550-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211550-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211550-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211550-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211550-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211550-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211550-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211550-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211550-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211550-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211550-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211550-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211550-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211550-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211550-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211550-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211550-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: EZETIMIBE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EZETIMIBE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EOR26LQQ24	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349556	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
ceecdbe9-5404-4a93-a488-9211cd103058	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-433-01	EZETIMIBE	100 in 1 BOTTLE	TABLET	100	10
16729-433-10	EZETIMIBE	30 in 1 BOTTLE	TABLET	30	10
16729-433-15	EZETIMIBE	90 in 1 BOTTLE	TABLET	90	10
16729-433-16	EZETIMIBE	500 in 1 BOTTLE	TABLET	500	10
16729-433-17	EZETIMIBE	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-433-10	EA - Each	16729-433	68b14c59-c681-4e1a-a609-b92c4438da64	1	2019-11-12
16729-433-15	EA - Each	16729-433	e0a39356-e208-4116-b8a5-86069ba3e50b	1	2019-11-12
16729-433-16	EA - Each	16729-433	e7d2fc2b-15ba-413b-ae18-901ae7858a98	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-433	EZETIMIBE TABLET [ACCORD HEALTHCARE INC.]	9	Current NDC, Legacy NDC, 5 package rows	20240712_ceecdbe9-5404-4a93-a488-9211cd103058.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
EZETIMIBE	EZETIMIBE	Accord Healthcare Inc.	ceecdbe9-5404-4a93-a488-9211cd103058	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211550 application number: ANDA211550 ndc (product): 16729-433

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	ceecdbe9-5404-4a93-a488-9211cd103058	10
349556	ezetimibe 10 MG Oral Tablet	SCD	ceecdbe9-5404-4a93-a488-9211cd103058	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-433-01	16729043301	100 in 1 BOTTLE						Historical
16729-433-10	16729043310	30 TABLET in 1 BOTTLE (16729-433-10)	30 tablet	2019-11-01	0000-00-00	No	No	Current
16729-433-15	16729043315	90 TABLET in 1 BOTTLE (16729-433-15)	90 tablet	2019-10-07	0000-00-00	No	No	Current
16729-433-16	16729043316	500 TABLET in 1 BOTTLE (16729-433-16)	500 tablet	2019-10-17	0000-00-00	No	No	Current
16729-433-17	16729043317	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EZETIMIBE	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	10
EZETIMIBE	REMEDYREPACK INC.	2024-04-01	HUMAN PRESCRIPTION DRUG LABEL	3