NDC 70518-1487

Tivicay

Dolutegravir Sodium

Tivicay is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Dolutegravir Sodium.

Product ID70518-1487_78765cc3-2749-0373-e053-2991aa0a7fe1
NDC70518-1487
Product TypeHuman Prescription Drug
Proprietary NameTivicay
Generic NameDolutegravir Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-06
Marketing CategoryNDA / NDA
Application NumberNDA204790
Labeler NameREMEDYREPACK INC.
Substance NameDOLUTEGRAVIR SODIUM
Active Ingredient Strength50 mg/1
Pharm ClassesHIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1487-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1487-0)
Marketing Start Date2018-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1487-0 [70518148700]

Tivicay TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204790
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-06

Drug Details

Active Ingredients

IngredientStrength
DOLUTEGRAVIR SODIUM50 mg/1

OpenFDA Data

SPL SET ID:1721d6f9-8ef7-40c0-8842-ecfe8346a56d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1433879
  • 1433873

    • Pharmacological Class

    • HIV Integrase Inhibitors [MoA]
    • Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
    • Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Tivicay" or generic name "Dolutegravir Sodium"

    NDCBrand NameGeneric Name
    49702-226Tivicaydolutegravir sodium
    49702-227Tivicaydolutegravir sodium
    49702-228Tivicaydolutegravir sodium
    50090-1355Tivicaydolutegravir sodium
    53808-1130Tivicaydolutegravir sodium
    67296-1818Tivicaydolutegravir sodium
    70518-1487Tivicaydolutegravir sodium
    49702-255Tivicay PDdolutegravir sodium

    Trademark Results [Tivicay]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIVICAY
    TIVICAY
    77509933 not registered Dead/Abandoned
    GLAXOSMITHKLINE LLC
    2008-06-27
    TIVICAY
    TIVICAY
    77063119 3618019 Live/Registered
    VIIV HEALTHCARE COMPANY
    2006-12-13
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