FDA.reportPublic FDA data

simvastatin 10 MG Oral Tablet

RxCUI
314231
RxNorm name
simvastatin 10 MG Oral Tablet
Display name
simvastatin 10 MG Oral Tablet
Full name
simvastatin 10 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINREMEDYREPACK INC.5ae78a86-ccca-4714-b77e-7bc885b674b52026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC522d0f7f-f20b-bc17-e063-6294a90a36482026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 314231
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.aa8aed58-691b-472e-8e98-53d0d3f566862026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINAurobindo Pharma Limited4724dbb4-3613-4e6a-948f-a43d34f97f062026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINCoupler LLC50733b85-067d-99c3-e063-6394a90a42442026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINREMEDYREPACK INC.807e5be4-6f87-48b4-8a3b-e4ad1061e7062026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINGolden State Medical Supply, Inc.4cc35f5f-2d3e-dedd-e063-6294a90a5cbe2026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINA-S Medication Solutionse4d8ebf3-7f9f-4725-a104-1d1bf6e6f7682026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINA-S Medication Solutions0ccb324f-877d-4f32-a769-7cd1637b7fad2026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINPD-Rx Pharmaceuticals, Inc.25d9f841-31d8-4514-ac73-ffe138ff69c72026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINBryant Ranch Prepack76ea62f3-4efb-4649-829d-3f0c28d5dae72026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINXLCare Pharmaceuticals Inc.433f8a86-5ad3-43db-8e62-c0812dd3d7232026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.3e48217f-8175-4e9b-9fd0-909be4bbba952026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 314231
simvastatinSIMVASTATINNorthwind Health Company, LLCdb0f4c5a-e8e4-3ab1-e053-2995a90a1f9a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 314231
SIMVASTATINSIMVASTATINAphena Pharma Solutions - Tennessee, LLC450e722c-d55d-3e6d-e063-6394a90a52312025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINA-S Medication Solutions468f87c8-75e3-444a-baeb-2d0f629802db2025-11-26Warnings, Adverse reactionsExact identifier
rxcui: 314231
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINAmerican Health Packaging4bec3923-6221-4b8b-9a72-872a63680de12025-08-25Warnings, Adverse reactionsExact identifier
rxcui: 314231
SimvastatinSIMVASTATINWestminster Pharmaceuticals, LLCacaaab63-c9ff-44c9-8fde-9a4ea6454dd72025-04-21Warnings, Adverse reactionsExact identifier
rxcui: 314231

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 56 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
522d0f7f-f20b-bc17-e063-6294a90a3648simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21SIMVASTATIN TABLETS. These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120260519
50733b85-067d-99c3-e063-6394a90a4244simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120260427
433f8a86-5ad3-43db-8e62-c0812dd3d723simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120260119
450e722c-d55d-3e6d-e063-6394a90a5231simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120251203
468f87c8-75e3-444a-baeb-2d0f629802dbsimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120251126
7fc4df06-48cb-481a-b7b2-d951def683easimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120231225
dad0dd7d-3049-4be4-aaeb-8a1895d55208simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120230501
37860f3f-984e-419a-a262-3bacc766953esimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120211213
121b0e00-abb7-4e07-a7b2-311be89fabb7simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets for oral use Initial U.S. Approval: 199120190325
fdcf0255-08d8-441e-be06-c8968ca340b4simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 199120180628
ef3c6f57-2729-4e32-8e7f-cd91d0cb713fsimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets USP for oral use Initial U.S. Approval: 199120140930
0f878e82-7ce1-450b-abb0-2090c22b389bsimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets USP for oral use Initial U.S. Approval: 199120140131
904fc6ad-08cd-4f2b-b0ad-cd0361a1dc02simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin. Simvastatin Tablets USP for oral use Initial U.S. Approval: 199120130930
c20229c8-719f-4950-b878-ba78d3e461basimvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 199120130930
330e35ed-fd6b-4123-864a-a5aa339c24d6simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets USP Initial U.S. Approval: 199120111227
364238c7-11b0-442e-acd9-4a6f21b9d783simvastatin 10 MG Oral Tablet [PSN] · simvastatin 10 MG Oral Tablet [SCD]21SIMVASTATIN20101201