NDC 0006-3069

PIFELTRO

Doravirine

PIFELTRO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Doravirine.

Product ID0006-3069_113e4ddb-b842-4e29-8391-f7b1520acf79
NDC0006-3069
Product TypeHuman Prescription Drug
Proprietary NamePIFELTRO
Generic NameDoravirine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-07-20
Marketing CategoryNDA / NDA
Application NumberNDA210806
Labeler NameMerck Sharp & Dohme Corp.
Substance NameDORAVIRINE
Active Ingredient Strength100 mg/1
Pharm ClassesHuman Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0006-3069-01

30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)
Marketing Start Date2018-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-3069-01 [00006306901]

PIFELTRO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-20

Drug Details

Active Ingredients

IngredientStrength
DORAVIRINE100 mg/1

OpenFDA Data

SPL SET ID:76ce1f00-28c0-4314-bd2c-d473fe3d0970
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2055766
  • 2055760
  • UPC Code
  • 0300063069014
  • Pharmacological Class

    • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Non-Nucleoside Analog [EXT]

    NDC Crossover Matching brand name "PIFELTRO" or generic name "Doravirine"

    NDCBrand NameGeneric Name
    0006-3069PIFELTROdoravirine
    50090-6237PIFELTROdoravirine
    50090-6268PIFELTROdoravirine

    Trademark Results [PIFELTRO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PIFELTRO
    PIFELTRO
    87107184 5807242 Live/Registered
    Merck Sharp & Dohme Corp.
    2016-07-18

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