NDC 0115-1386

Ezetimibe and Simvastatin

Ezetimibe And Simvastatin

Ezetimibe and Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Ezetimibe; Simvastatin.

Product ID0115-1386_468e8135-899e-47d8-b620-23e6c208f9db
NDC0115-1386
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe and Simvastatin
Generic NameEzetimibe And Simvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-04-26
Marketing End Date2020-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA201890
Labeler NameImpax Generics
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

Packaging

NDC 0115-1386-08

30 TABLET, FILM COATED in 1 BOTTLE (0115-1386-08)
Marketing Start Date2017-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1386-08 [00115138608]

Ezetimibe and Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201890
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-26
Marketing End Date2020-05-31

NDC 0115-1386-03 [00115138603]

Ezetimibe and Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201890
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-26
Marketing End Date2020-05-31

NDC 0115-1386-10 [00115138610]

Ezetimibe and Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201890
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-26
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:e6baf4f9-ed65-4bfe-bfd0-3780d79bcbc2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476345
  • 476351
  • 476350
  • 476349
    • UPC Code
  • 0301151385108
  • 0301151386105
  • 0301151387102
  • 0301151388109

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67877-507Ezetimibe and SimvastatinEzetimibe and Simvastatin
    67877-508Ezetimibe and SimvastatinEzetimibe and Simvastatin
    67877-509Ezetimibe and SimvastatinEzetimibe and Simvastatin
    67877-510Ezetimibe and SimvastatinEzetimibe and Simvastatin
    69238-1155Ezetimibe and SimvastatinEzetimibe and Simvastatin
    69238-1156Ezetimibe and SimvastatinEzetimibe and Simvastatin
    69238-1158Ezetimibe and SimvastatinEzetimibe and Simvastatin
    69238-1157Ezetimibe and SimvastatinEzetimibe and Simvastatin
    70518-1955Ezetimibe and SimvastatinEzetimibe and Simvastatin
    70518-1850Ezetimibe and SimvastatinEzetimibe and Simvastatin
    45963-567Ezetimibe and SimvastatinEzetimibe and Simvastatin
    45963-566Ezetimibe and SimvastatinEzetimibe and Simvastatin
    45963-568Ezetimibe and SimvastatinEzetimibe and Simvastatin
    50090-3479Ezetimibe and SimvastatinEzetimibe and Simvastatin
    50090-3486Ezetimibe and SimvastatinEzetimibe and Simvastatin
    50090-3984Ezetimibe and SimvastatinEzetimibe and Simvastatin
    60429-881Ezetimibe and SimvastatinEzetimibe and Simvastatin
    60429-882Ezetimibe and SimvastatinEzetimibe and Simvastatin
    60429-880Ezetimibe and SimvastatinEzetimibe and Simvastatin
    60429-879Ezetimibe and SimvastatinEzetimibe and Simvastatin
    62559-702Ezetimibe and SimvastatinEzetimibe and Simvastatin
    62559-700Ezetimibe and SimvastatinEzetimibe and Simvastatin
    62559-703Ezetimibe and SimvastatinEzetimibe and Simvastatin
    62559-701Ezetimibe and SimvastatinEzetimibe and Simvastatin
    51407-190Ezetimibe and SimvastatinEzetimibe and Simvastatin
    51407-193Ezetimibe and SimvastatinEzetimibe and Simvastatin
    51407-191Ezetimibe and SimvastatinEzetimibe and Simvastatin
    51407-192Ezetimibe and SimvastatinEzetimibe and Simvastatin
    68462-322ezetimibe and simvastatinezetimibe and simvastatin
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