Ezetimibe

Product NDC: 0781-5690
Requested package NDC: 0781-5690-05
11-digit product format: 007815690
Labeler code: 0781
Product ID: 0781-5690_ddb5fbb1-d7d0-418f-93b1-4cbcb573e1d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA203931
Marketing category: ANDA
Marketing start: 2017-06-12
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-5690	0781-5690-05	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203931-001	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
A203931-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203931-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203931-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203931-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203931-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203931-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203931-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203931-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203931-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203931-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203931-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203931-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203931-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203931-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203931-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203931-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203931-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203931-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203931-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203931-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203931-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203931-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203931-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203931-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203931-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203931-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203931-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203931-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203931-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203931-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203931-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203931-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203931-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203931-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203931-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203931-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203931-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203931-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203931-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203931-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203931-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0781-5690-05	Ezetimibe	500 in 1 BOTTLE	TABLET	500	6
0781-5690-31	Ezetimibe	30 in 1 BOTTLE	TABLET	30	6
0781-5690-92	Ezetimibe	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5690-05	EA - Each	0781-5690	a20df6b3-9452-438d-94cd-952082a47318	1	2017-07-07
0781-5690-31	EA - Each	0781-5690	61ecf5d1-4c52-46f4-bb60-12788c92a8f4	1	2017-07-07
0781-5690-92	EA - Each	0781-5690	7a3ae5e9-9d5e-49cb-9b48-314894661e78	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-5690	EZETIMIBE TABLET [SANDOZ INC]	6	Legacy NDC, 3 package rows	20240807_ebcb6655-fd60-4099-8099-be911c5b32ae.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	03609879-bad2-4e75-83fe-1e1a2fd300c3	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203931 application number: ANDA203931
Ezetimibe	EZETIMIBE	Proficient Rx LP	5cbd9bce-e02d-440f-95d5-4eb958d2f4f3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203931 application number: ANDA203931

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	ebcb6655-fd60-4099-8099-be911c5b32ae	6
349556	ezetimibe 10 MG Oral Tablet	SCD	ebcb6655-fd60-4099-8099-be911c5b32ae	6
349556	ezetimibe 10 MG Oral Tablet	PSN	03609879-bad2-4e75-83fe-1e1a2fd300c3	4
349556	ezetimibe 10 MG Oral Tablet	SCD	03609879-bad2-4e75-83fe-1e1a2fd300c3	4
349556	ezetimibe 10 MG Oral Tablet	PSN	5cbd9bce-e02d-440f-95d5-4eb958d2f4f3	3
349556	ezetimibe 10 MG Oral Tablet	SCD	5cbd9bce-e02d-440f-95d5-4eb958d2f4f3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5690-05	00781569005	500 TABLET in 1 BOTTLE (0781-5690-05)	500 tablet	2017-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ezetimibe	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	4
Ezetimibe	REMEDYREPACK INC.	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	3
Ezetimibe	Sandoz Inc	2024-03-11	HUMAN PRESCRIPTION DRUG LABEL	6
Ezetimibe	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3