FDA.reportPublic FDA data

NDC 66582-313-01 - 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
66582-313
Requested NDC
66582-313-01
Package NDCs from labels
66582-313-31, 66582-313-54, 66582-313-74, 66582-313-86, 66582-313-01, 66582-313-52, 66582-313-27
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2022-03-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VYTORIN - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2022-03-07HUMAN PRESCRIPTION DRUG LABEL
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
VYTORIN - Rebel Distributors CorpRebel Distributors Corp2010-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66582-313-31EA - Each66582-313f5a0c56b-9e41-4008-8210-4abe93a99f4012012-07-24
66582-313-54EA - Each66582-313bcb56bc9-5869-47b8-a039-c2bff32e53bb12012-07-24
66582-313-74EA - Each66582-31325f151d7-3f75-47ca-adfa-1fc83cd5a08f12012-07-24
66582-313-86EA - Each66582-313e5abeb51-591b-4538-88bd-7fef1d1e6b7c12012-07-24

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 [PD-RX PHARMACEUTICALS, INC.]22
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]22
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
ezetimibeACTIVE INGREDIENTEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1

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 6 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
SIMVASTATINSIMVASTATINAphena Pharma Solutions - Tennessee, LLC450e722c-d55d-3e6d-e063-6394a90a52312025-12-03Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions468f87c8-75e3-444a-baeb-2d0f629802db2025-11-26Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
ZetiaEZETIMIBEOrganon LLC174e45e0-45bb-48b7-9e60-8f6cfc1d22bb2025-11-25Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
SimvastatinSIMVASTATINA-S Medication Solutions02245025-218d-4297-aeb6-91fefa1782912025-11-25Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions20fa794a-c30a-485e-9e69-3818ba085a0d2025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions9986b59c-aeff-4ccd-8db3-7f1c4e6194202025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions7cbf645d-b1d3-413d-a4c3-c1818ed6dfd12025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 476351
rxcui: 476345
rxcui: 476349
rxcui: 476350
unii: AGG2FN16EV
unii: EOR26LQQ24
SimvastatinSIMVASTATINA-S Medication Solutions4312637b-1d6a-4d26-a1e8-caffcd7192df2025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutionsa2b879ae-eaf3-4a36-abd0-986add4a73ac2025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions66777aaa-370a-4121-9246-c0866098f4a42025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SimvastatinSIMVASTATINA-S Medication Solutions658cf877-f7cd-4ec8-84a3-08c27a06ccda2025-11-24Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
unii: 2968PHW8QP
EzetimibeEZETIMIBEMarlex Pharmaceuticals, Inc.109a22f4-a7cb-96c6-e063-6394a90ad7f62025-11-07Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24

Reported adverse events (FAERS/openFDA)#

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