VYTORIN

Product NDC: 21695-339
11-digit product format: 216950339
Labeler code: 21695
Product ID: 21695-339_65e1c3ae-a462-4345-8a28-c7d2c0388af8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ezetimibe and simvastatin
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021687
Marketing category: NDA
Marketing start: 2004-07-23
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-339		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-339	21695-339-30	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-339-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-339-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-339-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-339-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-339-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-339-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-339-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-339-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-339-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-339-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-339-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-339-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-339-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-339-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-339-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-339-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-339-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-339-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-339-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-339-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-339-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-339-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
N021687-001	VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23
N021687-002	VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23
N021687-003	VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23
N021687-004	VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021687-001	AB
N021687-002	AB
N021687-003	AB
N021687-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021687-001	VYTORIN	10MG;10MG	TABLET / ORAL	AB	RLD	2004-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-002	VYTORIN	10MG;20MG	TABLET / ORAL	AB	RLD	2004-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-003	VYTORIN	10MG;40MG	TABLET / ORAL	AB	RLD	2004-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-004	VYTORIN	10MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-07-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N021687-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021687-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021687-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021687-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021687-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021687-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021687-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021687-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021687-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021687-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021687-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021687-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021687-004	AB	1	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-339-30	2019-09-24	C162847	48780-1	934fe258-4b5d-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use VYTORIN safely and effectively. See full prescribing information for VYTORIN. VYTORIN (ezetimibe/simvastatin) Tablets Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-339-30	VYTORIN	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-339-30	EA - Each	21695-339	49705c7d-d634-489b-8170-ca53b41a50a0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
ezetimibe	ACTIVE MOIETY	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
simvastatin	ACTIVE MOIETY	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-339	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20101210_65e1c3ae-a462-4345-8a28-c7d2c0388af8.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
VYTORIN	EZETIMIBE AND SIMVASTATIN	Organon LLC	89b860d2-de83-468e-b7e8-76aeec2edca2	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021687 application number: NDA021687

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
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245430	Vytorin 10 MG / 20 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245441	Vytorin 10 MG / 40 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245449	Vytorin 10 MG / 80 MG Oral Tablet	PSN	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245430	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet [Vytorin]	SBD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245441	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet [Vytorin]	SBD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245449	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet [Vytorin]	SBD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	SCD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	SCD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	SCD	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245430	Vytorin 10/20 (ezetimibe 10 MG / simvastatin 20 MG) Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245430	Vytorin 10/20 Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245441	Vytorin 10/40 (ezetimibe 10 MG / simvastatin 40 MG) Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245441	Vytorin 10/40 Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245449	Vytorin 10/80 (ezetimibe 10 MG / simvastatin 80 MG) Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1
1245449	Vytorin 10/80 Oral Tablet	SY	65e1c3ae-a462-4345-8a28-c7d2c0388af8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-339-30	21695033930	30 in 1 BOTTLE	Historical