Ezetimibe and Simvastatin

Product NDC: 69238-1158
Requested package NDC: 69238-1158-3
11-digit product format: 692381158
Labeler code: 69238
Product ID: 69238-1158_73b04380-a0cd-4177-a5fc-4f0f8b675f2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe and Simvastatin
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA208831
Marketing category: ANDA
Marketing start: 2017-11-21
Marketing end: 0000-00-00
Substance: EZETIMIBE; SIMVASTATIN
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69238-1158	69238-1158-3	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A208831-001	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET / ORAL	2017-11-21
A208831-002	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET / ORAL	2017-11-21
A208831-003	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET / ORAL	2017-11-21
A208831-004	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET / ORAL	2017-11-21

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 5 · 172 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	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL		2017-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL		2017-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL		2017-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL		2017-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL		2017-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL		2017-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL		2017-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL		2017-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL		2017-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL		2017-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL		2017-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL		2017-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL		2017-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL		2017-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL		2017-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL		2017-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL		2017-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL		2017-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL		2017-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL		2017-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-11-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208831-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208831-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208831-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208831-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208831-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208831-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208831-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208831-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208831-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208831-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208831-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208831-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208831-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208831-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208831-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208831-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208831-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208831-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208831-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208831-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208831-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208831-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208831-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208831-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208831-004	AB	1	`1e350fbaab3a…`

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
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
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
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1158-3	Ezetimibe and Simvastatin	30 in 1 BOTTLE	TABLET	30		13
69238-1158-9	Ezetimibe and Simvastatin	90 in 1 BOTTLE	TABLET	90		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1158-3	EA - Each	69238-1158	7a844803-8fc9-4f36-9f56-171e775370ad	1	2018-01-12
69238-1158-9	EA - Each	69238-1158	c6e5eb78-2639-44f7-87b7-904e2f4db9bd	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1158	EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC]	13	Legacy NDC, 2 package rows	20250427_5ea3ca31-cfee-4978-8b7a-755986f6b091.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476345	ezetimibe 10 MG / simvastatin 10 MG Oral Tablet	PSN	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	PSN	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	PSN	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	PSN	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476345	ezetimibe 10 MG / simvastatin 10 MG Oral Tablet	SCD	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	SCD	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	SCD	5ea3ca31-cfee-4978-8b7a-755986f6b091	13
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	SCD	5ea3ca31-cfee-4978-8b7a-755986f6b091	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1158-3	69238115803	30 TABLET in 1 BOTTLE (69238-1158-3)	30 tablet	2017-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ezetimibe and Simvastatin	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	13