NDC 0006-3076

PREVYMIS

Letermovir

PREVYMIS 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 Letermovir.

Product ID0006-3076_15b7076c-fc58-4fe4-8549-ccfb47914a26
NDC0006-3076
Product TypeHuman Prescription Drug
Proprietary NamePREVYMIS
Generic NameLetermovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-08
Marketing CategoryNDA / NDA
Application NumberNDA209939
Labeler NameMerck Sharp & Dohme Corp.
Substance NameLETERMOVIR
Active Ingredient Strength480 mg/1
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 0006-3076-02

4 DOSE PACK in 1 CARTON (0006-3076-02) > 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01)
Marketing Start Date2017-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-3076-03 [00006307603]

PREVYMIS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209939
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-08

NDC 0006-3076-04 [00006307604]

PREVYMIS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209939
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-08

NDC 0006-3076-02 [00006307602]

PREVYMIS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209939
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-08

NDC 0006-3076-01 [00006307601]

PREVYMIS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209939
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-08

Drug Details

Active Ingredients

IngredientStrength
LETERMOVIR480 mg/1

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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