Ezetimibe and Simvastatin

Product NDC
42291-079
11-digit product format
422910079
Labeler code
42291
Product ID
42291-079_ea379ef9-ddc8-ef34-e053-2995a90a6db3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA208831
Marketing category
ANDA
Marketing start
2022-10-04
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-079DDiscontinued by firm2026-10-05
excluded packagepackage42291-07942291-079-10DDiscontinued by firm2026-10-05

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-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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-079-10EA - Each42291-079ed3c967f-6e7f-46a4-96ee-4cd2ffab962a12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-079EZETIMIBE AND SIMVASTATIN TABLET [AVKARE]2Legacy NDC20240110_ea37adb0-a162-42d9-e053-2995a90aeaad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-079-10422910079101000 TABLET in 1 BOTTLE (42291-079-10) 1000 tablet2022-10-040000-00-00NoNoCurrent