NDC 50090-3984

Ezetimibe and Simvastatin

Ezetimibe And Simvastatin

Ezetimibe and Simvastatin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Ezetimibe; Simvastatin.

Product ID50090-3984_61f1a059-0309-4d53-a8d8-ab73fbf6886c
NDC50090-3984
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe and Simvastatin
Generic NameEzetimibe And Simvastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-24
Marketing CategoryANDA / ANDA
Application NumberANDA208831
Labeler NameA-S Medication Solutions
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 Through2020-12-31

Packaging

NDC 50090-3984-0

90 TABLET in 1 BOTTLE (50090-3984-0)
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3984-0 [50090398400]

Ezetimibe and Simvastatin TABLET
Marketing CategoryANDA
Application NumberANDA208831
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:fc205122-d66a-41cc-bfce-8e4c109f2f50
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476350

    • 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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