NDC 63629-7413

Ezetimibe

Ezetimibe

Ezetimibe is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ezetimibe.

Product ID63629-7413_c89ce235-1211-4857-a2a9-a5098b7bfbe4
NDC63629-7413
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe
Generic NameEzetimibe
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA203931
Labeler NameBryant Ranch Prepack
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 63629-7413-1

30 TABLET in 1 BOTTLE (63629-7413-1)
Marketing Start Date2017-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-7413-3 [63629741303]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA203931
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 63629-7413-1 [63629741301]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA203931
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 63629-7413-5 [63629741305]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA203931
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 63629-7413-4 [63629741304]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA203931
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

NDC 63629-7413-2 [63629741302]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA203931
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-12

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:03609879-bad2-4e75-83fe-1e1a2fd300c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349556
  • Pharmacological Class

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