NDC 50090-0550

EPIVIR

Lamivudine

EPIVIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Lamivudine.

Product ID50090-0550_919f0d67-a0da-4ad8-a12a-e0c0922cd4be
NDC50090-0550
Product TypeHuman Prescription Drug
Proprietary NameEPIVIR
Generic NameLamivudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-10-04
Marketing CategoryNDA / NDA
Application NumberNDA020564
Labeler NameA-S Medication Solutions
Substance NameLAMIVUDINE
Active Ingredient Strength150 mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-0550-0

60 TABLET, FILM COATED in 1 BOTTLE (50090-0550-0)
Marketing Start Date2014-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-0550-0 [50090055000]

EPIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-28
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
LAMIVUDINE150 mg/1

OpenFDA Data

SPL SET ID:6f823564-b8db-4f69-8b9a-398c4de4c555
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199147
  • 152931
  • Pharmacological Class

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

    NDC Crossover Matching brand name "EPIVIR" or generic name "Lamivudine"

    NDCBrand NameGeneric Name
    0173-0662EPIVIRlamivudine
    0173-0663EPIVIRlamivudine
    21695-367EPIVIRlamivudine
    49702-203EPIVIRlamivudine
    49702-204EPIVIRlamivudine
    49702-205EPIVIRlamivudine
    50090-0550EPIVIRlamivudine
    53808-0245EPIVIREPIVIR
    53808-0246EPIVIREPIVIR
    0904-6583LAMIVUDINElamivudine
    10135-605LamivudineLamivudine
    31722-001lamivudinelamivudine
    31722-752LamivudineLamivudine
    31722-753LamivudineLamivudine
    31722-754LamivudineLamivudine
    33342-001LamivudineLamivudine
    33342-002LamivudineLamivudine

    Trademark Results [EPIVIR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPIVIR
    EPIVIR
    78906783 3227835 Live/Registered
    VIIV HEALTHCARE COMPANY
    2006-06-13
    EPIVIR
    EPIVIR
    74213040 1981308 Live/Registered
    VIIV HEALTHCARE COMPANY
    1991-10-11

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