Ezetimibe and Simvastatin

Product NDC
62559-701
11-digit product format
625590701
Labeler code
62559
Product ID
62559-701_61c89be9-44b0-42ca-bedd-1c0b65662757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA208831
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
2023-03-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62559-701DDiscontinued by firm2026-10-05
excluded packagepackage62559-70162559-701-30DDiscontinued by firm2026-10-05
excluded packagepackage62559-70162559-701-90DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage62559-701-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62559-701-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62559-701-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62559-701-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62559-701-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62559-701-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62559-701-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62559-701-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62559-701-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62559-701-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62559-701-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62559-701-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62559-701-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62559-701-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62559-701-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62559-701-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62559-701-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62559-701-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62559-701-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62559-701-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62559-701-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62559-701-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62559-701-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62559-701-90557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208831-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-21
A208831-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-21
A208831-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-21
A208831-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-2184e616aacf4f…
2026-09-14 22:38:342026-08A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-2184e616aacf4f…
2026-09-14 22:38:342026-08A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-2184e616aacf4f…
2026-09-14 22:38:342026-08A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-2184e616aacf4f…
2026-08-18 06:07:402026-07A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-11-215bbf6a4d5a75…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208831-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208831-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208831-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208831-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208831-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208831-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208831-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208831-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208831-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208831-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208831-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208831-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208831-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208831-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208831-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208831-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208831-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208831-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208831-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208831-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208831-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208831-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208831-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208831-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208831-004AB11e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-701-30EA - Each62559-701ba0fbf7e-4052-4e81-8a30-ddec1be5f7e512018-10-11
62559-701-90EA - Each62559-701746d7866-c633-46d4-8a9c-a3e0f3df79ff12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-701-306255907013030 TABLET in 1 BOTTLE (62559-701-30) 30 tablet2018-09-240000-00-00NoNoCurrent
62559-701-906255907019090 TABLET in 1 BOTTLE (62559-701-90) 90 tablet2018-09-240000-00-00NoNoCurrent