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United States · US · US:64678-010_bf0186cb-f9bf-49ea-904b-6f8dd72a2590
Tembexa
Orange BookUNIISPLATC J05AB17
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEmergent BioDefense Operations Lansing LLC
CountryUS (United States)
ATC codeJ05AB17
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164678010014 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-01)
- ndc1164678010024 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-02)
Annotations
UNII (FDA Substance ID)
6794O900AX
BRINCIDOFOVIR
RxCUI 2599518
Orange Book
N214461
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6794O900AX",
"rxcui": "2599518",
"inchikey": "WXJFKKQWPMNTIM-VWLOTQADSA-N",
"display_name": "BRINCIDOFOVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"209aa94b-c613-4880-ad89-41be83d12c0a": {
"match": "brand_token",
"title": "TEMBEXA (BRINCIDOFOVIR) TABLET, FILM COATED [EMERGENT BIODEFENSE OPERATIONS LANSING LLC]",
"spl_version": "2",
"published_date": "2026-03-16"
}
},
"productid": "64678-010_bf0186cb-f9bf-49ea-904b-6f8dd72a2590",
"productndc": "64678-010",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214461",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 4, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRINCIDOFOVIR",
"proprietary_name": "Tembexa",
"active_ingred_unit": "mg/1",
"application_number": "NDA214461",
"marketing_category": "NDA",
"nonproprietary_name": "Brincidofovir",
"start_marketing_date": "20220420",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J05AB17.
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