prevymis

Generic: letermovir

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prevymis
Generic Name letermovir
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

letermovir 20 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5003
Product ID 0006-5003_282d792e-e2f2-4744-8526-4d18427c55cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209940
Listing Expiration 2027-12-31
Marketing Start 2017-11-08

Pharmacologic Class

Established (EPC)
cytomegalovirus dna terminase complex inhibitor [epc]
Mechanism of Action
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065003
Hyphenated Format 0006-5003

Supplemental Identifiers

RxCUI
1988652 1988657 1988660 1988661 1988666 1988671 1988673 1988675 2693185 2693189 2693191 2693193
UNII
1H09Y5WO1F
NUI
N0000193800 N0000193801 N0000190114 N0000190107 N0000190108 N0000187062 N0000185507 N0000185607

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prevymis (source: ndc)
Generic Name letermovir (source: ndc)
Application Number NDA209940 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)
source: ndc

Packages (1)

0006-5003-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)

Ingredients (1)

letermovir (20 mg/mL)

Linked Drug Pages (1)

PREVYMIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "282d792e-e2f2-4744-8526-4d18427c55cb", "openfda": {"nui": ["N0000193800", "N0000193801", "N0000190114", "N0000190107", "N0000190108", "N0000187062", "N0000185507", "N0000185607"], "unii": ["1H09Y5WO1F"], "rxcui": ["1988652", "1988657", "1988660", "1988661", "1988666", "1988671", "1988673", "1988675", "2693185", "2693189", "2693191", "2693193"], "spl_set_id": ["1b49df80-be4f-47e0-a0b7-123f3e69395b"], "pharm_class_epc": ["Cytomegalovirus DNA Terminase Complex Inhibitor [EPC]"], "pharm_class_moa": ["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]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01)  / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)", "package_ndc": "0006-5003-01", "marketing_start_date": "20171108"}], "brand_name": "PREVYMIS", "product_id": "0006-5003_282d792e-e2f2-4744-8526-4d18427c55cb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "0006-5003", "generic_name": "LETERMOVIR", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREVYMIS", "active_ingredients": [{"name": "LETERMOVIR", "strength": "20 mg/mL"}], "application_number": "NDA209940", "marketing_category": "NDA", "marketing_start_date": "20171108", "listing_expiration_date": "20271231"}