NDC 52959-546

COMBIVIR

Lamivudine And Zidovudine

COMBIVIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Lamivudine; Zidovudine.

Product ID52959-546_37641156-8d51-4e36-abb6-b46cb9e7f828
NDC52959-546
Product TypeHuman Prescription Drug
Proprietary NameCOMBIVIR
Generic NameLamivudine And Zidovudine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-10-19
Marketing CategoryNDA / NDA
Application NumberNDA020857
Labeler NameH.J. Harkins Company, Inc.
Substance NameLAMIVUDINE; ZIDOVUDINE
Active Ingredient Strength150 mg/1; 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],Human Immunodeficiency 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 52959-546-20

20 TABLET, FILM COATED in 1 BOTTLE (52959-546-20)
Marketing Start Date2010-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-546-15 [52959054615]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-02 [52959054602]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-10 [52959054610]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-20 [52959054620]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-08 [52959054608]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-14 [52959054614]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-28 [52959054628]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-04 [52959054604]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-06 [52959054606]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

NDC 52959-546-03 [52959054603]

COMBIVIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020857
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-19
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
LAMIVUDINE150 mg/1

OpenFDA Data

SPL SET ID:479a2784-8db2-4fe5-94ba-55316a3c4e4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200082
  • 213088

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

    NDC Crossover Matching brand name "COMBIVIR" or generic name "Lamivudine And Zidovudine"

    NDCBrand NameGeneric Name
    21695-846COMBIVIRlamivudine and zidovudine
    49702-202COMBIVIRlamivudine and zidovudine
    50090-0610COMBIVIRlamivudine and zidovudine
    52959-546COMBIVIRlamivudine and zidovudine
    53808-0895COMBIVIRlamivudine and zidovudine
    21695-996Lamivudine and ZidovudineLamivudine and Zidovudine
    31722-506LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINE
    31722-739Lamivudine and ZidovudineLamivudine and Zidovudine
    33342-003Lamivudine and ZidovudineLamivudine and Zidovudine
    42291-363Lamivudine and ZidovudineLamivudine and Zidovudine
    43063-346Lamivudine and ZidovudineLamivudine and Zidovudine
    43063-900lamiVUDine and ZIDOVUDINElamiVUDine and ZIDOVUDINE
    50090-3920LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINE
    50268-456LAMIVUDINE and ZIDOVUDINELAMIVUDINE and ZIDOVUDINE
    50436-0597Lamivudine and ZidovudineLamivudine and Zidovudine
    54741-102Lamivudine and Zidovudinelamivudine and zidovudine
    55700-096Lamivudine and ZidovudineLamivudine and Zidovudine
    57297-284LAMIVUDINE AND ZIDOVUDINELAMIVUDINE AND ZIDOVUDINE
    63629-4872Lamivudine and ZidovudineLamivudine and Zidovudine
    64380-707Lamivudine and ZidovudineLamivudine and Zidovudine
    65862-036Lamivudine and ZidovudineLamivudine and Zidovudine
    65862-597Lamivudine and ZidovudineLamivudine and Zidovudine

    Trademark Results [COMBIVIR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COMBIVIR
    COMBIVIR
    75244811 2158546 Live/Registered
    VIIV HEALTHCARE COMPANY
    1997-02-20
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