FDA.reportPublic FDA data

simvastatin 5 MG Oral Tablet

RxCUI
312962
RxNorm name
simvastatin 5 MG Oral Tablet
Display name
simvastatin 5 MG Oral Tablet
Full name
simvastatin 5 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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimvastatinSIMVASTATINBryant Ranch Prepacka3bfe314-1fe4-4d2a-aecb-4194f3bd8f222026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINAurobindo Pharma Limited4724dbb4-3613-4e6a-948f-a43d34f97f062026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 312962
simvastatinSIMVASTATINBryant Ranch Prepackc03ab80c-a3ae-4634-a76b-f53740db76f52026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINGolden State Medical Supply, Inc.4cc35f5f-2d3e-dedd-e063-6294a90a5cbe2026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINXLCare Pharmaceuticals Inc.433f8a86-5ad3-43db-8e62-c0812dd3d7232026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 312962
SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.3e48217f-8175-4e9b-9fd0-909be4bbba952026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINA-S Medication Solutions4312637b-1d6a-4d26-a1e8-caffcd7192df2025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINA-S Medication Solutionsa2b879ae-eaf3-4a36-abd0-986add4a73ac2025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 312962
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432025-09-25Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINQuallent Pharmaceuticals Health LLC2b4255a7-f9f5-4235-8dbb-b0f03acbd6242024-07-23Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINNorthStar Rx LLC0376351b-f1a0-43e5-a0b4-533072c49f392024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINCamber Pharmaceuticals, Inc.751b79c6-bba8-4d29-b69c-a2ac6453fec82024-04-05Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINBiocon Pharma Inc,7b325108-6940-50a7-96b4-822a5206e5682023-09-26Warnings, Adverse reactionsExact identifier
rxcui: 312962
SimvastatinSIMVASTATINA-S Medication Solutions34c8c080-97b5-4580-b8fb-3fd557cdb40a2023-05-03Warnings, Adverse reactionsExact identifier
rxcui: 312962

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 29 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5c1c694c-4b08-469e-b538-08e69df06146simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]290400These 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: 199120230821
c03ab80c-a3ae-4634-a76b-f53740db76f5simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]2105These 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: 199120260403
a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]2101These 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: 199120240403
4724dbb4-3613-4e6a-948f-a43d34f97f06simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]229These 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: 199120260511
0376351b-f1a0-43e5-a0b4-533072c49f39simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]224These 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: 199120240415
3e48217f-8175-4e9b-9fd0-909be4bbba95simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]223These 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: 199120260113
871251c0-36a1-4a32-9eab-ff6c1e925ca9simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]222These 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: 199120251114
7b325108-6940-50a7-96b4-822a5206e568simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]212These 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: 199120230926
751b79c6-bba8-4d29-b69c-a2ac6453fec8simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]210These 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: 199120240405
cdb54447-86a5-4924-a7de-ec170f86651dsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 199120140328
9f89e53e-a8fb-4ba7-a26d-21a962abcb1bsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin. SIMVASTATIN TABLETS, USP Initial U.S. Approval: 199120120905
2b4255a7-f9f5-4235-8dbb-b0f03acbd624simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]26These 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: 199120240723
a9415031-0643-42f6-a162-662433fc1071simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 199120120529
4f0bca7b-5acc-4297-a529-9eebcad9f684simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use simvastatin tablets USP safely and effectively. See full prescribing information for simvastatin tablets USP. SIMVASTATIN tablets USP for oral use Initial U.S. Approval: 199120170706
593f0007-9690-4de5-b1e9-59299e587643simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]23These 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: 199120250925
aecec1e2-93e5-f93c-84fe-dab201fe8a06simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]23These 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: 199120210416
4cc35f5f-2d3e-dedd-e063-6294a90a5cbesimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]22SIMVASTATIN 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: 199120260326
1d7c107b-64f3-41b0-88c5-4f38dc58ceafsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]22These 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: 199120191219
7ad38e3b-79a8-f4c1-0662-c24f3e897ac7simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]22These 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: 199120151217
7f4de1cc-c5aa-4e2c-a603-51818d8367efsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]22These 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: 199120150118
433f8a86-5ad3-43db-8e62-c0812dd3d723simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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
4312637b-1d6a-4d26-a1e8-caffcd7192dfsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120251124
a2b879ae-eaf3-4a36-abd0-986add4a73acsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120251124
26b9a3a9-56e7-00b4-e063-6394a90a7d3esimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120241112
34c8c080-97b5-4580-b8fb-3fd557cdb40asimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120230503
11d83725-d646-4ad4-9930-956beb793ea0simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120170227
b1f2911f-f8e1-41c0-9979-cb8d683d2f2fsimvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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: 199120120417
364238c7-11b0-442e-acd9-4a6f21b9d783simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 MG Oral Tablet [SCD]21SIMVASTATIN20101201
7fce939e-c38e-497f-ba3f-e7b6ba44bfd9simvastatin 5 MG Oral Tablet [PSN] · simvastatin 5 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. Initial U.S. Approval: 199120100825