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United States · US · US:50072-200_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
    5007220042
    42 CAPSULE in 1 BOTTLE (50072-200-42)

Annotations

UNII (FDA Substance ID)
SB96YO2BR8
TECOVIRIMAT MONOHYDRATE
RxCUI 2055103
Orange Book
N208627
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SB96YO2BR8",
    "rxcui": "2055103",
    "inchikey": "QRHXYGPOQKLBJP-NPIFKJBVSA-N",
    "display_name": "TECOVIRIMAT MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "50072-200_474526fb-5357-880e-e063-6294a90a3296",
  "productndc": "50072-200",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208627",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jul 13, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECOVIRIMAT MONOHYDRATE",
  "proprietary_name": "TPOXX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208627",
  "marketing_category": "NDA",
  "nonproprietary_name": "tecovirimat monohydrate",
  "start_marketing_date": "20180831",
  "active_numerator_strength": "200"
}

Related drugs

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