Ezetimibe and Simvastatin

Product NDC
0115-1385
11-digit product format
001151385
Labeler code
0115
Product ID
0115-1385_468e8135-899e-47d8-b620-23e6c208f9db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EZETIMIBE and SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Impax Generics
Application
ANDA201890
Marketing category
ANDA
Marketing start
2017-04-26
Marketing end
2020-05-31
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
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0115-1385DDiscontinued by firm2026-08-17
excluded packagepackage0115-13850115-1385-03DDiscontinued by firm2026-08-17
excluded packagepackage0115-13850115-1385-08DDiscontinued by firm2026-08-17
excluded packagepackage0115-13850115-1385-10DDiscontinued by firm2026-08-17

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1385-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1385-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1385-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1385-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1385-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1385-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1385-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1385-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1385-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1385-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1385-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1385-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1385-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1385-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1385-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1385-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1385-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1385-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1385-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1385-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1385-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1385-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1385-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1385-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1385-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1385-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1385-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1385-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1385-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1385-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1385-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1385-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1385-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1385-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1385-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1385-08557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201890-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26
A201890-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26
A201890-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26
A201890-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201890-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201890-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201890-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201890-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A201890-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201890-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201890-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201890-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201890-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201890-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201890-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201890-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201890-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201890-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201890-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201890-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201890-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201890-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201890-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201890-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201890-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201890-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201890-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201890-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201890-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201890-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201890-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201890-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201890-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201890-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201890-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201890-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201890-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201890-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201890-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201890-004AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1385-03EA - Each0115-138503d28a63-34bd-4686-bfb4-113c2048c55b12017-05-03
0115-1385-08EA - Each0115-1385e3dae525-2914-4577-a34a-02bc4ed2c3e012017-05-03
0115-1385-10EA - Each0115-138563891e71-08be-434e-a56f-260e872faeb012017-05-03