United States· US:64678-012_8ce2edcc-3c73-4a58-b96e-c7ba5408d3c9

Tembexa

A brincidofovir product containing brincidofovir, registered in United States by Emergent BioDefense Operations Lansing LLC.

ATC J05AB17US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedTembexaATCJ05AB17REGISTER NO.US:64678-012_8ce2edcc…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BRINCIDOFOVIR
Manufacturer
Emergent BioDefense Operations Lansing LLC
Country
United States (US)
ATC code
J05AB17
ATC class
Brincidofovir
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    64678-012-01
  • ndc11
    64678-012-02
  • ndc11
    64678-012-03
  • ndc11
    64678-012-04
  • ndc11
    6467801201
    65 mL in 1 BOTTLE (64678-012-01)
  • ndc11
    6467801202
    65 mL in 1 BOTTLE (64678-012-02)
  • ndc11
    6467801203
    1 BOTTLE in 1 CARTON (64678-012-03) / 45 mL in 1 BOTTLE
  • ndc11
    6467801204
    1 BOTTLE in 1 CARTON (64678-012-04) / 45 mL in 1 BOTTLE

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same class

Other records under J05AB17

Brincidofovir, as other registers publish it.

All brincidofovir products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/580ed3fe-b815-4a70-80eb-6fa3f9048cdd
GET /v1/drugs/580ed3fe-b815-4a70-80eb-6fa3f9048cdd?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "10",
  "substance": "BRINCIDOFOVIR",
  "productndc": "64678-012",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA214460",
  "marketing_category": "NDA"
}

See everything about brincidofovir.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.