NDC 10135-615

Entecavir

Entecavir

Entecavir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Entecavir.

Product ID10135-615_ba3e8d2f-b611-4242-9b6b-e0fbc57e64a6
NDC10135-615
Product TypeHuman Prescription Drug
Proprietary NameEntecavir
Generic NameEntecavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA206652
Labeler NameMarlex Pharmaceuticals Inc
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10135-615-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-615-30)
Marketing Start Date2016-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-615-30 [10135061530]

Entecavir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206652
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ENTECAVIR.5 mg/1

OpenFDA Data

SPL SET ID:aa3d6d9a-ec31-4d66-8151-ec3bfad799e9
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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