NDC 55289-280

VYTORIN

Ezetimibe And Simvastatin

VYTORIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Ezetimibe; Simvastatin.

Product ID55289-280_7abb7688-35bb-9c4c-e053-2991aa0a158d
NDC55289-280
Product TypeHuman Prescription Drug
Proprietary NameVYTORIN
Generic NameEzetimibe And Simvastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-07-23
Marketing CategoryNDA / NDA
Application NumberNDA021687
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameEZETIMIBE; SIMVASTATIN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-280-30

30 TABLET in 1 BOTTLE, PLASTIC (55289-280-30)
Marketing Start Date2011-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-280-30 [55289028030]

VYTORIN TABLET
Marketing CategoryNDA
Application NumberNDA021687
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-01

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:f70e7022-0c44-48f2-9f7e-606e7ac730aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476350
  • 1245441
  • Pharmacological Class

    • Decreased Cholesterol Absorption [PE]
    • Dietary Cholesterol Absorption Inhibitor [EPC]
    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "VYTORIN" or generic name "Ezetimibe And Simvastatin"

    NDCBrand NameGeneric Name
    21695-325VYTORINezetimibe and simvastatin
    21695-339VYTORINezetimibe and simvastatin
    21695-827VYTORINezetimibe and simvastatin
    55289-520VYTORINVYTORIN
    55289-280VYTORINVYTORIN
    66582-311VYTORINVYTORIN
    66582-313VYTORINVYTORIN
    66582-315VYTORINVYTORIN
    66582-312VYTORINVYTORIN
    0115-1385Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
    0115-1386Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
    0115-1387Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
    0115-1388Ezetimibe and SimvastatinEZETIMIBE and SIMVASTATIN
    16714-778ezetimibe and simvastatinezetimibe and simvastatin
    16714-779ezetimibe and simvastatinezetimibe and simvastatin
    16714-780ezetimibe and simvastatinezetimibe and simvastatin
    16714-781ezetimibe and simvastatinezetimibe and simvastatin
    42291-078Ezetimibe and SimvastatinEzetimibe and Simvastatin
    42291-079Ezetimibe and SimvastatinEzetimibe and Simvastatin
    42291-080Ezetimibe and SimvastatinEzetimibe and Simvastatin
    42291-081Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-583Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-584Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-585Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-586Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-742Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-743Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-744Ezetimibe and SimvastatinEzetimibe and Simvastatin
    43598-745Ezetimibe and SimvastatinEzetimibe and Simvastatin
    45963-565Ezetimibe and SimvastatinEzetimibe and Simvastatin

    Trademark Results [VYTORIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VYTORIN
    VYTORIN
    76492611 2946492 Live/Registered
    MSD INTERNATIONAL GMBH
    2003-02-25

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