FDA.reportPublic FDA data

NDC 66582-311-01 - VYTORIN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
66582-311
Requested NDC
66582-311-01
Package NDCs from labels
66582-311-31, 66582-311-54, 66582-311-82, 66582-311-87, 66582-311-01, 66582-311-28
Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2020-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VYTORIN - Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp.2020-12-05HUMAN PRESCRIPTION DRUG LABEL
VYTORIN - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-09-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66582-311-31EA - Each66582-31103b64cf0-6fc8-470e-b49d-8d81fce2f66e12012-07-24
66582-311-54EA - Each66582-311cb586942-6d4c-4305-a4d5-f0575e589b2012012-07-24
66582-311-82EA - Each66582-3115324c251-0a7a-481b-839e-2b77a2c2bd1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ezetimibeACTIVE INGREDIENTEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]43
ezetimibeACTIVE INGREDIENTEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2

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 13 · 243 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 476351
rxcui: 476345
rxcui: 476349
rxcui: 476350
unii: AGG2FN16EV
unii: EOR26LQQ24
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.68f6c856-ea98-4872-b4df-a6e9e70444fc2026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.3f6fad0b-0278-433f-86db-761b673a58032026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432026-08-27Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINCardinal Health 107, LLCb2d6c7ac-304b-4cba-974c-d9a23a0699252026-08-25Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
SimvastatinSIMVASTATINREMEDYREPACK INC.d053fee4-b797-4a82-8865-0b4d08b149902026-08-19Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC58cd6c9a-3429-24eb-e063-6394a90a69842026-08-11Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
SIMVASTATINSIMVASTATINREMEDYREPACK INC.e59bf31f-d880-4d9e-b6c2-5a18a53718f92026-08-06Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SIMVASTATINSIMVASTATINA-S Medication Solutionse447cc46-adee-4126-8b85-f00f81a6e93c2026-07-08Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC55f92c72-e690-85dd-e063-6394a90adb392026-07-06Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
EzetimibeEZETIMIBEA-S Medication Solutions090776cf-f211-49a3-a993-ff5d707311f22026-07-06Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutionsa1cc2018-72a3-48bc-90de-c460f224cf5a2026-07-06Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
SIMVASTATINSIMVASTATINSt. Mary's Medical Park Pharmacyf94d5907-737e-df67-e053-6394a90a82a62026-07-01Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINBryant Ranch Prepacka3bfe314-1fe4-4d2a-aecb-4194f3bd8f222026-06-29Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV

Reported adverse events (FAERS/openFDA)#

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