NDC 21695-339

VYTORIN

Ezetimibe And Simvastatin

VYTORIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Ezetimibe; Simvastatin.

Product ID21695-339_65e1c3ae-a462-4345-8a28-c7d2c0388af8
NDC21695-339
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 NameRebel Distributors Corp
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-339-30

30 TABLET in 1 BOTTLE (21695-339-30)
Marketing Start Date2004-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-339-30 [21695033930]

VYTORIN TABLET
Marketing CategoryNDA
Application NumberNDA021687
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-23
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:65e1c3ae-a462-4345-8a28-c7d2c0388af8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245430
  • 476351
  • 476350
  • 1245449
  • 476349
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.