NDC 62227-102

Entecavir

Entecavir

Entecavir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Brightgene Bio-medical Technology Co., Ltd.. The primary component is Entecavir.

Product ID62227-102_93aacb75-6d1e-b5f1-e053-2a95a90abb2a
NDC62227-102
Product TypeHuman Prescription Drug
Proprietary NameEntecavir
Generic NameEntecavir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-08
Marketing CategoryANDA / ANDA
Application NumberANDA212126
Labeler NameBrightGene Bio-Medical Technology Co., Ltd.
Substance NameENTECAVIR
Active Ingredient Strength1 mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62227-102-01

30 TABLET in 1 BOTTLE, PLASTIC (62227-102-01)
Marketing Start Date2019-03-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62227-102-02 [62227010202]

Entecavir TABLET
Marketing CategoryANDA
Application NumberANDA212126
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-08

NDC 62227-102-01 [62227010201]

Entecavir TABLET
Marketing CategoryANDA
Application NumberANDA212126
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-08

Drug Details

Active Ingredients

IngredientStrength
ENTECAVIR1 mg/1

OpenFDA Data

SPL SET ID:f3cad54a-090a-4eb3-a16c-8ae4073cf023
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485434
  • 485436

    • Pharmacological Class

    • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0093-5786EntecavirEntecavir
    0093-5787EntecavirEntecavir
    10135-615EntecavirEntecavir
    10135-616EntecavirEntecavir
    16714-717ENTECAVIRENTECAVIR
    16714-718ENTECAVIRENTECAVIR
    16729-388EntecavirEntecavir
    16729-389EntecavirEntecavir
    31722-833EntecavirEntecavir
    31722-834EntecavirEntecavir
    42291-261EntecavirEntecavir
    42291-262EntecavirEntecavir
    68382-920EntecavirEntecavir
    68382-921EntecavirEntecavir
    69097-425ENTECAVIRENTECAVIR
    69097-426ENTECAVIRENTECAVIR
    70771-1019EntecavirEntecavir
    70771-1020EntecavirEntecavir
    43547-437ENTECAVIRENTECAVIR
    43547-436ENTECAVIRENTECAVIR
    49884-547EntecavirEntecavir
    49884-548EntecavirEntecavir
    51407-065EntecavirEntecavir
    51407-064EntecavirEntecavir
    52343-147ENTECAVIRENTECAVIR
    51991-896EntecavirEntecavir
    51991-895EntecavirEntecavir
    52343-148ENTECAVIRENTECAVIR
    60687-216EntecavirEntecavir
    65162-446EntecavirEntecavir
    65862-842EntecavirEntecavir
    65162-449EntecavirEntecavir
    65862-841EntecavirEntecavir
    62227-102EntecavirEntecavir
    62227-101EntecavirEntecavir
    0003-1611BARACLUDEentecavir
    0003-1612BARACLUDEentecavir
    0003-1614BARACLUDEentecavir
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