NDC 0006-5003

PREVYMIS

Letermovir

PREVYMIS is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Letermovir.

Product ID0006-5003_15b7076c-fc58-4fe4-8549-ccfb47914a26
NDC0006-5003
Product TypeHuman Prescription Drug
Proprietary NamePREVYMIS
Generic NameLetermovir
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-08
Marketing CategoryNDA / NDA
Application NumberNDA209940
Labeler NameMerck Sharp & Dohme Corp.
Substance NameLETERMOVIR
Active Ingredient Strength20 mg/mL
Pharm ClassesCytomegalovirus DNA Terminase Complex Inhibitor [EPC],DNA Terminase Complex Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-5003-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) > 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)
Marketing Start Date2017-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-5003-01 [00006500301]

PREVYMIS INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-08

NDC 0006-5003-02 [00006500302]

PREVYMIS INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-08

Drug Details

Active Ingredients

IngredientStrength
LETERMOVIR20 mg/mL

OpenFDA Data

SPL SET ID:1b49df80-be4f-47e0-a0b7-123f3e69395b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1988666
  • 1988652
  • 1988657
  • 1988673
  • 1988671
  • 1988661
  • 1988660
  • 1988675
  • Pharmacological Class

    • Cytomegalovirus DNA Terminase Complex Inhibitor [EPC]
    • DNA Terminase Complex Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
    • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]

    NDC Crossover Matching brand name "PREVYMIS" or generic name "Letermovir"

    NDCBrand NameGeneric Name
    0006-3075PREVYMISLETERMOVIR
    0006-3076PREVYMISLETERMOVIR
    0006-5003PREVYMISLETERMOVIR
    0006-5004PREVYMISLETERMOVIR

    Trademark Results [PREVYMIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREVYMIS
    PREVYMIS
    86665070 5492520 Live/Registered
    Merck Sharp & Dohme Corp.
    2015-06-17

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