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United States · US · US:50072-010_474526fb-5357-880e-e063-6294a90a3296

TPOXX

Orange BookUNIISPLATC J05AX24

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

Identification

ManufacturerSIGA Technologies, Inc.
CountryUS (United States)
ATC codeJ05AX24
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5007201001
    7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30)

Annotations

UNII (FDA Substance ID)
F925RR824R
TECOVIRIMAT
RxCUI 2055104
Orange Book
N214518
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "F925RR824R",
    "rxcui": "2055104",
    "inchikey": "CSKDFZIMJXRJGH-VWLPUNTISA-N",
    "display_name": "TECOVIRIMAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "fce826ab-4d6a-4139-a2ee-a304a913a253": {
      "match": "brand_token",
      "title": "TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.]",
      "spl_version": "17",
      "published_date": "2026-01-06"
    }
  },
  "productid": "50072-010_474526fb-5357-880e-e063-6294a90a3296",
  "productndc": "50072-010",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "214518",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/20ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "May 18, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECOVIRIMAT",
  "proprietary_name": "TPOXX",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA214518",
  "marketing_category": "NDA",
  "nonproprietary_name": "tecovirimat monohydrate",
  "start_marketing_date": "20220531",
  "active_numerator_strength": "10"
}

Related drugs

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