United States· US:0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8

Choletec

A medicinal product containing mebrofenin, registered in United States by Bracco Diagnostics Inc.

US 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…normalisedCholetecATC—REGISTER NO.US:0270-0083_c9c87a8e…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
MEBROFENIN
Manufacturer
Bracco Diagnostics Inc
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0270008320
    10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
  • ndc11
    0270-0083-20

Regulatory notes

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

Same medicine, other countries

Mebrofenin in 6 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mebrofenin products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Hungary · Bromo-Biliaron
  • Poland · Poltechmbrida

Source: European Medicines Agency, Article 57 product data.

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/91d525e2-4c40-4078-acb5-51f6648d2b13
GET /v1/drugs/91d525e2-4c40-4078-acb5-51f6648d2b13?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "45",
  "substance": "MEBROFENIN",
  "productndc": "0270-0083",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA018963",
  "marketing_category": "NDA"
}

See everything about mebrofenin.

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.