NDC 68462-226

Ezetimibe

Ezetimibe

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

Product ID68462-226_126d4745-c8ad-4bfc-b684-d6a3f8c4972f
NDC68462-226
Product TypeHuman Prescription Drug
Proprietary NameEzetimibe
Generic NameEzetimibe
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA078560
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameEZETIMIBE
Active Ingredient Strength10 mg/1
Pharm ClassesDecreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68462-226-05

500 TABLET in 1 BOTTLE (68462-226-05)
Marketing Start Date2022-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-226-10 [68462022610]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA078560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-07-31

NDC 68462-226-05 [68462022605]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA078560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-07-31

NDC 68462-226-30 [68462022630]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA078560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-07-31

NDC 68462-226-11 [68462022611]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA078560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-07-31

NDC 68462-226-90 [68462022690]

Ezetimibe TABLET
Marketing CategoryANDA
Application NumberANDA078560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
EZETIMIBE10 mg/1

OpenFDA Data

SPL SET ID:ac539a72-77e4-419c-b1d9-42002e9cecf7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349556

    • 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
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