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United States · US · US:64678-012_8ce2edcc-3c73-4a58-b96e-c7ba5408d3c9
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 · 4
- ndc11646780120165 mL in 1 BOTTLE (64678-012-01)
- ndc11646780120265 mL in 1 BOTTLE (64678-012-02)
- ndc1164678012031 BOTTLE in 1 CARTON (64678-012-03) / 45 mL in 1 BOTTLE
- ndc1164678012041 BOTTLE in 1 CARTON (64678-012-04) / 45 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
6794O900AX
BRINCIDOFOVIR
RxCUI 2599518
Orange Book
N214460
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": "64678-012_8ce2edcc-3c73-4a58-b96e-c7ba5408d3c9",
"productndc": "64678-012",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "214460",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/ML",
"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/mL",
"application_number": "NDA214460",
"marketing_category": "NDA",
"nonproprietary_name": "Brincidofovir",
"start_marketing_date": "20220420",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J05AB17.
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