JOURNAVX

Orange BookUNIISPL

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

Identification

ManufacturerVertex Pharmaceuticals Incorporated

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5116754825
5 BLISTER PACK in 1 CARTON (51167-548-25) / 5 TABLET, FILM COATED in 1 BLISTER PACK (51167-548-05)
ndc11
5116754830
30 TABLET, FILM COATED in 1 BOTTLE (51167-548-30)
ndc11
5116754831
100 TABLET, FILM COATED in 1 BOTTLE (51167-548-31)
ndc11
5116754834
10 BLISTER PACK in 1 CARTON (51167-548-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

LOG73M21H5

SUZETRIGINE

Orange Book

N219209

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LOG73M21H5",
    "rxcui": null,
    "inchikey": "XSQUJFKRXZMOKA-PAFIKIDNSA-N",
    "display_name": "SUZETRIGINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f0976da4-1d20-4517-945c-b60ed2f41c12": {
      "match": "brand_token",
      "title": "JOURNAVX (SUZETRIGINE) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED]",
      "spl_version": "9",
      "published_date": "2026-04-16"
    }
  },
  "productid": "51167-548_6af8a930-2a29-428c-96da-94045a1f7d4e",
  "productndc": "51167-548",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219209",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUZETRIGINE",
  "proprietary_name": "JOURNAVX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219209",
  "marketing_category": "NDA",
  "nonproprietary_name": "Suzetrigine",
  "start_marketing_date": "20250130",
  "active_numerator_strength": "50"
}

Access this data programmatically

Query JOURNAVX and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs