Ezetimibe

Product NDC: 0615-8300
11-digit product format: 006158300
Labeler code: 0615
Product ID: 0615-8300_0318598c-29b9-4e48-a29b-c22266595eb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA209838
Marketing category: ANDA
Marketing start: 2017-08-25
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: 2020-12-31
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	0615-8300		D	Discontinued by firm	2026-08-03
excluded package	package	0615-8300	0615-8300-05	D	Discontinued by firm	2026-08-03
excluded package	package	0615-8300	0615-8300-39	D	Discontinued by firm	2026-08-03

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
A209838-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209838-001	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	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`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	A209838-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	AB	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8300	EZETIMIBE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	3	Legacy NDC	20250330_f30c3cb1-fb91-4f69-b181-bfb4238635af.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	A-S Medication Solutions	090776cf-f211-49a3-a993-ff5d707311f2	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	a1cc2018-72a3-48bc-90de-c460f224cf5a	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	3a80b668-51cd-42be-8497-8712b0508422	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Aurobindo Pharma Limited	726b1e63-437a-4b3b-b773-3ac47a5c0f38	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	NorthStar Rx LLC	5f5644a9-e019-4e5d-ab6f-3d30b1024c5a	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	63ecbbf1-a6de-493f-9710-812ff45cb4d3	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	57d19491-cba1-4720-b69d-481574459201	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Proficient Rx LP	8b128e52-5d0d-4536-aa1f-be192d0989ad	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8300-39	00615830039	30 TABLET in 1 BLISTER PACK (0615-8300-39)	30 tablet	2019-07-03	0000-00-00	No	No	Current