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United States · US · US:73292-011_0e3b8e29-64dd-430f-998d-5aca82258a8d

Viltepso

Orange BookUNIISPLATC M09AX12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNS Pharma, Inc.
CountryUS (United States)
ATC codeM09AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7329201101
    1 VIAL, GLASS in 1 CARTON (73292-011-01) / 1 INJECTION, SOLUTION in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
SXA7YP6EKX
VILTOLARSEN
RxCUI 2389840
Orange Book
N212154
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SXA7YP6EKX",
    "rxcui": "2389840",
    "inchikey": null,
    "display_name": "VILTOLARSEN",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123": {
      "match": "brand_token",
      "title": "VILTEPSO (VILTOLARSEN) INJECTION, SOLUTION [NS PHARMA, INC.]",
      "spl_version": "7",
      "published_date": "2025-07-21"
    }
  },
  "productid": "73292-011_0e3b8e29-64dd-430f-998d-5aca82258a8d",
  "productndc": "73292-011",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212154",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/5ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 12, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VILTOLARSEN",
  "proprietary_name": "Viltepso",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212154",
  "marketing_category": "NDA",
  "nonproprietary_name": "viltolarsen",
  "start_marketing_date": "20200813",
  "active_numerator_strength": "250"
}

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