PREVYMIS

Product NDC
0006-5085
11-digit product format
000065085
Labeler code
0006
Product ID
0006-5085_282d792e-e2f2-4744-8526-4d18427c55cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LETERMOVIR
Dosage form
PELLET
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA219104
Marketing category
NDA
Marketing start
2024-08-30
Substance
LETERMOVIR
Active strength
120 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1H09Y5WO1FLETERMOVIR917389-32-3LETERMOVIR

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-5085-010000650850130 PACKET in 1 CARTON (0006-5085-01) / 48 PELLET in 1 PACKET30 packet2024-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PREVYMISMerck Sharp & Dohme LLC2026-01-14HUMAN PRESCRIPTION DRUG LABEL28