PREVYMIS

Orange BookUNIISPLATC J05AX18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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

ndc11
0006508601
30 PACKET in 1 CARTON (0006-5086-01) / 8 PELLET in 1 PACKET

Annotations

UNII (FDA Substance ID)

1H09Y5WO1F

LETERMOVIR

RxCUI 1988648

Orange Book

N219104

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": "ORAL",
  "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": "0006-5086_282d792e-e2f2-4744-8526-4d18427c55cb",
  "productndc": "0006-5086",
  "dosage_form": "PELLET",
  "orange_book": {
    "appl_no": "219104",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/PACKET",
        "product_no": "001",
        "approval_date": "Aug 30, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "120MG/PACKET",
        "product_no": "002",
        "approval_date": "Aug 30, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LETERMOVIR",
  "proprietary_name": "PREVYMIS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219104",
  "marketing_category": "NDA",
  "nonproprietary_name": "LETERMOVIR",
  "start_marketing_date": "20240830",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code J05AX18.

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