FDA.reportPublic FDA data

ezetimibe 10 MG / simvastatin 10 MG Oral Tablet

RxCUI
476345
RxNorm name
ezetimibe 10 MG / simvastatin 10 MG Oral Tablet
Display name
ezetimibe 10 MG / simvastatin 10 MG Oral Tablet
Full name
ezetimibe 10 MG / simvastatin 10 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-08-24Warnings, Adverse reactionsExact identifier
rxcui: 476345
VYTORINEZETIMIBE AND SIMVASTATINOrganon LLC89b860d2-de83-468e-b7e8-76aeec2edca22026-01-21Warnings, Adverse reactionsExact identifier
rxcui: 476345
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 476345
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINDr.Reddys Laboratories Inc023ca87a-1b04-8c17-dc4f-e2758b0771e22025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 476345
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAscend Laboratories, LLCc90e8c96-e130-42d7-bf0d-5833652e40d52025-05-02Warnings, Adverse reactionsExact identifier
rxcui: 476345
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAmneal Pharmaceuticals NY LLC5ea3ca31-cfee-4978-8b7a-755986f6b0912025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 476345
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAurobindo Pharma Limited79dadfde-35c7-4937-9c82-1728fb6be2fb2024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 476345
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINGlenmark Pharmaceuticals Inc., USA32d0e130-1211-44ca-be60-5379ffec96fd2024-04-30Warnings, Adverse reactionsExact identifier
rxcui: 476345

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c90e8c96-e130-42d7-bf0d-5833652e40d5ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]216These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 200420250502
5ea3ca31-cfee-4978-8b7a-755986f6b091ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]213These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 200420250130
023ca87a-1b04-8c17-dc4f-e2758b0771e2ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS . EZETIMIBE AND SIMVASTATIN tablets for oral use Initial U.S. Approval: 200420250718
89b860d2-de83-468e-b7e8-76aeec2edca2ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use VYTORIN safely and effectively. See full prescribing information for VYTORIN. VYTORIN ® (ezetimibe and simvastatin) tablets, for oral use Initial U.S. Approval: 200420260121
88cd0e7b-e8dc-6125-e053-2a95a90aaa27ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]27EZETIMIBE AND SIMVASTATIN TABLETS. These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS . EZETIMIBE AND SIMVASTATIN tablets for oral use Initial U.S. Approval: 200420251124
52a46269-2262-4052-a3ff-5455523f591fezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE AND SIMVASTATIN tablets, for oral use Initial U.S. Approval: 200420240927
32d0e130-1211-44ca-be60-5379ffec96fdezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE AND SIMVASTATIN tablets, for oral use Initial U.S. Approval: 200420240430
79dadfde-35c7-4937-9c82-1728fb6be2fbezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 200420241022
2507c644-e445-4e31-8d15-82afcb15f274ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [PSN] · ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [SCD]22These 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: 200420120906