FDA.reportPublic FDA data

SIMVASTATIN

Substance profile for UNII AGG2FN16EV, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for SIMVASTATIN
Structure render from PubChem CID 54454

Substance Identity#

UNII
AGG2FN16EV
Preferred term
SIMVASTATIN
Registry number
79902-63-9
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C25H38O5
Chemical structure for SIMVASTATIN
Structure render from PubChem CID 54454

Chemical And Database Identifiers#

InChIKey
RYMZZMVNJRMUDD-HGQWONQESA-N
SMILES
CCC(C)(C)C(=O)O[C@H]1C[C@@H](C)C=C2C=C[C@H](C)[C@H](CC[C@@H]3C[C@@H](O)CC(=O)O3)[C@@H]12
RxCUI
36567
PubChem
54454
NCIt
C29454
INN ID
6147

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound54454pubchem.ncbi.nlm.nih.gov/compound/54454
PubChem InChIKey SearchRYMZZMVNJRMUDD-HGQWONQESA-Npubchem.ncbi.nlm.nih.gov/#query=RYMZZMVNJRMUDD-HGQWONQESA-N
RxNorm36567mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=36567
NCI ThesaurusC29454ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C29454
FDA Substance Registration SystemAGG2FN16EVprecision.fda.gov/uniisearch/srs/unii/AGG2FN16EV

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE MOIETYThese 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 for oral use Initial U.S. Approval: 199110
ACTIVE INGREDIENTThese 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 for oral use Initial U.S. Approval: 199110
ACTIVE INGREDIENTThese 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: 19912
ACTIVE MOIETYThese 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: 19912
ACTIVE INGREDIENTThese 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: 19914
ACTIVE MOIETYThese 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: 19914
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 199111
ACTIVE MOIETYThese 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: 199111
ACTIVE MOIETYThese 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, for oral use Initial U.S. Approval: 19911
ACTIVE INGREDIENTThese 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, for oral use Initial U.S. Approval: 19911
ACTIVE MOIETYThese 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: 199110
ACTIVE INGREDIENTThese 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: 199110
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 20042
ACTIVE MOIETYThese 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: 20042
ACTIVE INGREDIENTThese 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: 19917
ACTIVE MOIETYThese 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: 19917
ACTIVE MOIETYThese 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: 19913
ACTIVE INGREDIENTThese 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: 19913
ACTIVE MOIETYSimvastatin Tablets Tablet, Film Coated Rx Only. These highlights do not include all the information needed to use S imvastatin safely and effectively. See full prescribing information for S imvastatin. Simvastatin (Simvastatin) tablets for oral administration Initial U.S. Approval: 19912
ACTIVE INGREDIENTSimvastatin Tablets Tablet, Film Coated Rx Only. These highlights do not include all the information needed to use S imvastatin safely and effectively. See full prescribing information for S imvastatin. Simvastatin (Simvastatin) tablets for oral administration Initial U.S. Approval: 19912
ACTIVE INGREDIENTThese 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: 19916
ACTIVE MOIETYThese 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: 19916
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTThese 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: 19912
ACTIVE MOIETYThese 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: 19912
ACTIVE INGREDIENTThese 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: 19918
ACTIVE MOIETYThese 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: 19918
ACTIVE MOIETYThese 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: 19918
ACTIVE INGREDIENTThese 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: 19918
ACTIVE MOIETYSIMVASTATIN1
ACTIVE INGREDIENTSIMVASTATIN1
ACTIVE MOIETYThese 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: 20041
ACTIVE INGREDIENTThese 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: 20041
ACTIVE MOIETYThese 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: 19911
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE MOIETYThese highlights do not include all the information needed to use Simvastatin safely and effectively. See full prescribing information for Simvastatin. Initial U.S. Approval: 19911
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Simvastatin safely and effectively. See full prescribing information for Simvastatin. Initial U.S. Approval: 19911
ACTIVE INGREDIENTThese highlights do not include all the information needed to use SIMCOR ® safely and effectively. See full prescribing information for SIMCOR. SIMCOR (simvastatin/niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 20082
ACTIVE MOIETYThese highlights do not include all the information needed to use SIMCOR ® safely and effectively. See full prescribing information for SIMCOR. SIMCOR (simvastatin/niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 20082
ACTIVE MOIETYThese 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: 19911
ACTIVE INGREDIENTThese 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: 19911
ACTIVE INGREDIENTSIMVASTATIN TABLETS1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Simvastatin safely and effectively. See full prescribing information for Simvastatin. Initial U.S. Approval: 19911
ACTIVE MOIETYThese highlights do not include all the information needed to use Simvastatin safely and effectively. See full prescribing information for Simvastatin. Initial U.S. Approval: 19911
ACTIVE MOIETYSIMVASTATIN TABLETS1
ACTIVE INGREDIENTSIMVASTATIN ORALLY DISINTEGRATING TABLETS (SIMVASTATIN)1
ACTIVE MOIETYSIMVASTATIN ORALLY DISINTEGRATING TABLETS (SIMVASTATIN)1
ACTIVE INGREDIENTSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
ACTIVE MOIETYSIMVASTATIN TABLET [MICRO LABS LIMITED]90388
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3252
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3252
ACTIVE INGREDIENTZOCOR (SIMVASTATIN) TABLET, FILM COATED [LAKE ERIE MEDICAL SURGICAL & SUPPLY DBA QUALITY CARE PRODUCTS LLC]3061
ACTIVE MOIETYZOCOR (SIMVASTATIN) TABLET, FILM COATED [LAKE ERIE MEDICAL SURGICAL & SUPPLY DBA QUALITY CARE PRODUCTS LLC]3061
ACTIVE INGREDIENTSIMCOR (NIACIN AND SIMVASTATIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1449
ACTIVE MOIETYSIMCOR (NIACIN AND SIMVASTATIN) TABLET, FILM COATED, EXTENDED RELEASE [ABBVIE INC.]1449
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYVYTORIN (EZETIMIBE SIMVASTIN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]400
ACTIVE INGREDIENTVYTORIN (EZETIMIBE SIMVASTIN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]400
ACTIVE INGREDIENTVYTORIN (EZETIMIBE/SIMVASTIN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]369
ACTIVE MOIETYVYTORIN (EZETIMIBE/SIMVASTIN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]369
ACTIVE INGREDIENTVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
ACTIVE MOIETYVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
ACTIVE INGREDIENTSIMVASTATIN (SIMVASTATIN) TABLET [REMEDYREPACK INC. ]41
ACTIVE MOIETYSIMVASTATIN (SIMVASTATIN) TABLET [REMEDYREPACK INC. ]41
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]32
ACTIVE INGREDIENTZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]30
ACTIVE MOIETYZOCOR (SIMVASTATIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]30
ACTIVE MOIETYVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]24
ACTIVE INGREDIENTVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]24
ACTIVE INGREDIENTVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
ACTIVE MOIETYVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]20
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]20
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]17
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]17
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]14
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]14
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]13
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [BLU PHARMCEUTICALS LLC]11
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [BLU PHARMCEUTICALS LLC]11
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABS, INC.]11
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [INTERNATIONAL LABS, INC.]11
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]9
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC]9
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
ACTIVE INGREDIENTSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
ACTIVE MOIETYSIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8