NDC 0074-2625

Mavyret

Glecaprevir And Pibrentasvir

Mavyret is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Pibrentasvir; Glecaprevir.

Product ID0074-2625_0e23f7a3-4101-5c43-1c00-79bf2d875952
NDC0074-2625
Product TypeHuman Prescription Drug
Proprietary NameMavyret
Generic NameGlecaprevir And Pibrentasvir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-03
Marketing CategoryNDA / NDA
Application NumberNDA209394
Labeler NameAbbVie Inc.
Substance NamePIBRENTASVIR; GLECAPREVIR
Active Ingredient Strength40 mg/1; mg/1
Pharm ClassesHepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0074-2625-01

1 DOSE PACK in 1 CARTON (0074-2625-01) > 3 TABLET, FILM COATED in 1 DOSE PACK
Marketing Start Date2017-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0074-2625-28 [00074262528]

Mavyret TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209394
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-03

NDC 0074-2625-01 [00074262501]

Mavyret TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209394
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-03

NDC 0074-2625-56 [00074262556]

Mavyret TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209394
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-03

NDC 0074-2625-80 [00074262580]

Mavyret TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209394
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-27
Marketing End Date2020-04-14

Drug Details

Active Ingredients

IngredientStrength
PIBRENTASVIR40 mg/1

OpenFDA Data

SPL SET ID:7bf99777-0401-9095-8645-16c6e907fcc0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1940703
  • 1940709
  • Pharmacological Class

    • Hepatitis C Virus NS5A Inhibitor [EPC]
    • P-Glycoprotein Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]
    • UGT1A1 Inhibitors [MoA]
    • Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]
    • HCV NS3/4A Protease Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]
    • UGT1A1 Inhibitors [MoA]

    NDC Crossover Matching brand name "Mavyret" or generic name "Glecaprevir And Pibrentasvir"

    NDCBrand NameGeneric Name
    0074-2600MavyretGlecaprevir and Pibrentasvir
    0074-2625MavyretGlecaprevir and Pibrentasvir

    Trademark Results [Mavyret]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MAVYRET
    MAVYRET
    88488568 not registered Live/Pending
    AbbVie Inc.
    2019-06-25
    MAVYRET
    MAVYRET
    87375678 5361413 Live/Registered
    AbbVie Inc.
    2017-03-17

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