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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
- ndc1150072010017 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
Other records sharing ATC code J05AX24.
- NOTecovirimat sigaSIGA
- ISTecovirimat SIGASiga Technologies Netherlands B.V.
- PLTecovirimat SIGASIGA Technologies Netherland B.V.
- DKTecovirimat SIGASIGA Technologies Netherlands B.V.
- FITecovirimat SIGASIGA Technologies Netherlands B.V.
- CZTECOVIRIMAT SIGASIGA Technologies Netherlands B.V., Breda
- BETecovirimat Siga 200 mgSiga Technologies Netherlands
- IETecovirimat SIGA 200 mg hard capsulesSIGA Technologies Netherlands B.V.
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