NDC 49702-242

Juluca

Dolutegravir Sodium And Rilpivirine Hydrochloride

Juluca is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Viiv Healthcare Company. The primary component is Dolutegravir Sodium; Rilpivirine Hydrochloride.

Product ID49702-242_053c410a-58e9-480e-a911-60a3ec12f688
NDC49702-242
Product TypeHuman Prescription Drug
Proprietary NameJuluca
Generic NameDolutegravir Sodium And Rilpivirine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-21
Marketing CategoryNDA / NDA
Application NumberNDA210192
Labeler NameViiV Healthcare Company
Substance NameDOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesHIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49702-242-13

30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)
Marketing Start Date2017-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49702-242-13 [49702024213]

Juluca TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210192
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-21

Drug Details

Active Ingredients

IngredientStrength
DOLUTEGRAVIR SODIUM50 mg/1

OpenFDA Data

SPL SET ID:806653d1-bf35-4924-b999-ad5d21821cc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1989500
  • 1989506
  • UPC Code
  • 0349702242135
  • 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]
    • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Non-Nucleoside Analog [EXT]

    Medicade Reported Pricing

    49702024213 JULUCA 50-25 MG TABLET

    Pricing Unit: EA | Drug Type:

    Trademark Results [Juluca]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JULUCA
    JULUCA
    86934462 5059366 Live/Registered
    VIIV HEALTHCARE UK (NO. 3) LIMITED
    2016-03-09
    JULUCA
    JULUCA
    85686108 not registered Dead/Abandoned
    Glaxo Group Limited
    2012-07-25
    JULUCA
    JULUCA
    77521513 not registered Dead/Abandoned
    Glaxo Group Limited
    2008-07-14

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.