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United States· US:0268-8087_8c93c301-de0c-466d-b914-7ec864c7c0a6

AUREOBASIDIUM PULLULANS

A medicinal product containing aureobasidium pullulans var. pullutans, registered in United States by ALK-Abello, Inc..

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAUREOBASIDIUM PULLULANSATC—REGISTER NO.US:0268-8087_8c93c301…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AUREOBASIDIUM PULLULANS VAR. PULLUTANS
Manufacturer
ALK-Abello, 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 · 4

  • ndc11
    0268808710
    10.5 mL in 1 VIAL (0268-8087-10)
  • ndc11
    0268808750
    53 mL in 1 VIAL (0268-8087-50)
  • ndc11
    0268-8087-10
  • ndc11
    0268-8087-50

Regulatory notes

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

Same medicine, other countries

Aureobasidium pullulans var. pullutans in 2 other countries

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

All aureobasidium pullulans var. pullutans products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Germany · Prick-Testlösung Pullularia Pullulans, Provokations-Testlösung Pullularia Pullulans

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/e822b916-f90c-4571-881f-47435c584521
GET /v1/drugs/e822b916-f90c-4571-881f-47435c584521?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": "PERCUTANEOUS; SUBCUTANEOUS",
  "source": "ndc",
  "strength": ".05",
  "substance": "AUREOBASIDIUM PULLULANS VAR. PULLUTANS",
  "productndc": "0268-8087",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "g/mL",
  "application_number": "BLA103753",
  "marketing_category": "BLA"
}

See everything about aureobasidium pullulans var. pullutans.

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.