Ezetimibe

Product NDC: 0591-3713
Requested package NDC: 0591-3713-00
11-digit product format: 005913713
Labeler code: 0591
Product ID: 0591-3713_24aaf5ca-08e0-4db8-9734-cf2a606f8e57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA200831
Marketing category: ANDA
Marketing start: 2017-06-12
Marketing end: 2026-07-31
Substance: EZETIMIBE
Active strength: 10 mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0591-3713	0591-3713-00	UNFINISHED	Active or certified unfinished drug listing		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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A200831-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200831-001	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	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200831-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`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	A200831-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200831-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200831-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200831-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200831-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200831-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200831-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200831-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200831-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200831-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200831-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200831-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200831-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200831-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200831-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200831-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200831-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200831-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200831-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200831-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200831-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200831-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200831-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200831-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200831-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200831-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200831-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200831-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200831-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200831-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200831-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200831-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200831-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200831-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200831-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200831-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200831-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200831-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200831-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200831-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: No

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EZETIMIBE	10 mg/1

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
0591-3713-05	Ezetimibe	500 in 1 BOTTLE	TABLET	500	11
0591-3713-19	Ezetimibe	90 in 1 BOTTLE	TABLET	90	11
0591-3713-30	Ezetimibe	30 in 1 BOTTLE	TABLET	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3713-05	EA - Each	0591-3713	0232fbc4-ac9e-48de-b61d-dd8c532389a0	1	2017-10-13
0591-3713-19	EA - Each	0591-3713	ad9e0789-a362-491b-b740-0767a88b377b	1	2017-07-07
0591-3713-30	EA - Each	0591-3713	52c722aa-18fd-48d3-9486-a1377c9f45d3	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3713	EZETIMIBE TABLET [ACTAVIS PHARMA, INC.]	10	Current NDC, Legacy NDC, 3 package rows	20240601_f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba.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	Bryant Ranch Prepack	11828685-dc27-42d8-a6ff-f110018207d1	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200831 application number: ANDA200831

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	f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba	11
349556	ezetimibe 10 MG Oral Tablet	SCD	f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba	11
349556	ezetimibe 10 MG Oral Tablet	PSN	11828685-dc27-42d8-a6ff-f110018207d1	5
349556	ezetimibe 10 MG Oral Tablet	SCD	11828685-dc27-42d8-a6ff-f110018207d1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Status
0591-3713-00	00591371300	100000 TABLET in 1 BOX (0591-3713-00)	100000 tablet	12-JUN-17	28-FEB-27	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ezetimibe	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	5
Ezetimibe	Actavis Pharma, Inc.	2024-03-03	HUMAN PRESCRIPTION DRUG LABEL	11