NDC 53808-0811

ZIAGEN

Abacavir Sulfate

ZIAGEN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Abacavir Sulfate.

Product ID53808-0811_dd74d4f9-ed20-47b0-bb3d-4a8ad228a21e
NDC53808-0811
Product TypeHuman Prescription Drug
Proprietary NameZIAGEN
Generic NameAbacavir Sulfate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA020977
Labeler NameState of Florida DOH Central Pharmacy
Substance NameABACAVIR SULFATE
Active Ingredient Strength300 mg/1
Pharm ClassesHuman 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 53808-0811-1

1 TABLET, FILM COATED in 1 BLISTER PACK (53808-0811-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0811-1 [53808081101]

ZIAGEN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020977
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
ABACAVIR SULFATE300 mg/1

OpenFDA Data

SPL SET ID:ff62bcaa-a200-4ebf-a9ca-1ab2c254751c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213460
  • 242679
    • UPC Code
  • 0301730661012

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ZIAGEN" or generic name "Abacavir Sulfate"

    NDCBrand NameGeneric Name
    49702-221ZIAGENabacavir sulfate
    49702-222ZIAGENabacavir sulfate
    53808-0811ZIAGENabacavir sulfate
    64980-405AbacavirAbacavir Sulfate
    65862-089AbacavirAbacavir Sulfate
    68084-021AbacavirAbacavir Sulfate
    0378-4105Abacavir Sulfateabacavir sulfate
    0904-6523Abacavir SulfateAbacavir Sulfate
    51079-204Abacavir Sulfateabacavir sulfate
    53808-0627Abacavir Sulfateabacavir sulfate
    60505-3583Abacavir SulfateAbacavir Sulfate
    70518-0640Abacavir SulfateAbacavir Sulfate

    Trademark Results [ZIAGEN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZIAGEN
    ZIAGEN
    75262534 2248121 Live/Registered
    VIIV HEALTHCARE COMPANY
    1997-03-25
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