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United States · US · US:0006-5004_282d792e-e2f2-4744-8526-4d18427c55cb
PREVYMIS
Orange BookUNIISPLATC J05AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ05AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100065004011 VIAL, SINGLE-DOSE in 1 CARTON (0006-5004-01) / 24 mL in 1 VIAL, SINGLE-DOSE (0006-5004-02)
Annotations
UNII (FDA Substance ID)
1H09Y5WO1F
LETERMOVIR
RxCUI 1988648
Orange Book
N209940
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1H09Y5WO1F",
"rxcui": "1988648",
"inchikey": "FWYSMLBETOMXAG-QHCPKHFHSA-N",
"display_name": "LETERMOVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"1b49df80-be4f-47e0-a0b7-123f3e69395b": {
"match": "brand_token",
"title": "PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC]",
"spl_version": "28",
"published_date": "2026-01-23"
}
},
"productid": "0006-5004_282d792e-e2f2-4744-8526-4d18427c55cb",
"productndc": "0006-5004",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209940",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "240MG/12ML (20MG/ML)",
"product_no": "001",
"approval_date": "Nov 8, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "480MG/24ML (20MG/ML)",
"product_no": "002",
"approval_date": "Nov 8, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LETERMOVIR",
"proprietary_name": "PREVYMIS",
"active_ingred_unit": "mg/mL",
"application_number": "NDA209940",
"marketing_category": "NDA",
"nonproprietary_name": "LETERMOVIR",
"start_marketing_date": "20171108",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code J05AX18.
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