NDC 0591-3713

Ezetimibe

Ezetimibe

Ezetimibe is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Ezetimibe.

Product ID0591-3713_7c61610b-5ac6-42d4-8b1d-829936db901b
NDC0591-3713
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe
Generic NameEzetimibe
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA200831
Labeler NameActavis Pharma, Inc.
Substance NameEZETIMIBE
Active Ingredient Strength10 mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-3713-05

500 TABLET in 1 BOTTLE (0591-3713-05)
Marketing Start Date2017-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3713-10 [00591371310]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA200831
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-12
Marketing End Date2017-06-12

NDC 0591-3713-30 [00591371330]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA200831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-12

NDC 0591-3713-05 [00591371305]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA200831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-12

NDC 0591-3713-19 [00591371319]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA200831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-12

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349556
  • UPC Code
  • 0305913713307
  • Pharmacological Class

    • Decreased Cholesterol Absorption [PE]
    • Dietary Cholesterol Absorption Inhibitor [EPC]

    NDC Crossover Matching brand name "Ezetimibe" or generic name "Ezetimibe"

    NDCBrand NameGeneric Name
    0591-3713EzetimibeEzetimibe
    0615-8300EzetimibeEzetimibe
    0781-5690EzetimibeEzetimibe
    0904-6664EzetimibeEzetimibe
    0904-7103EzetimibeEzetimibe
    16714-813EzetimibeEzetimibe
    16729-433EZETIMIBEEZETIMIBE
    31722-628EZETIMIBEEZETIMIBE
    42291-314EzetimibeEzetimibe
    49884-228EzetimibeEzetimibe
    50090-2717EzetimibeEzetimibe
    50090-3087EzetimibeEzetimibe
    50090-3402EzetimibeEzetimibe
    50090-3422EzetimibeEzetimibe
    50090-3657EzetimibeEzetimibe
    50228-379EzetimibeEzetimibe
    50268-298EzetimibeEzetimibe
    51660-200EzetimibeEzetimibe
    59651-052EzetimibeEzetimibe
    60429-982EzetimibeEzetimibe
    60505-2945EzetimibeEzetimibe
    60687-284EzetimibeEzetimibe
    60687-373EzetimibeEzetimibe
    67877-490EzetimibeEzetimibe
    68382-773ezetimibeezetimibe
    68462-226EzetimibeEzetimibe
    69238-1154EzetimibeEzetimibe
    70518-1783EzetimibeEzetimibe
    70518-1927EzetimibeEzetimibe
    70771-1109ezetimibeezetimibe
    71205-145EzetimibeEzetimibe
    71335-0933EzetimibeEzetimibe
    63629-7413EzetimibeEzetimibe
    71205-277EzetimibeEzetimibe
    71335-1127EzetimibeEzetimibe
    70518-2262EzetimibeEzetimibe
    71335-1354EzetimibeEzetimibe
    21695-778ZetiaEzetimibe
    50090-0833ZetiaEzetimibe
    55154-5031ZetiaEzetimibe
    55154-5034ZetiaEzetimibe
    55154-5043ZetiaEzetimibe

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