United States· US:61938-456_49ede145-f336-f2b5-e063-6294a90aefce
INFASURF
A medicinal product containing calfactant, registered in United States by ONY Biotech Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- CALFACTANT
- Manufacturer
- ONY Biotech 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
- ndc1161938-456-03
- ndc1161938-456-06
- ndc1161938456031 VIAL, GLASS in 1 CARTON (61938-456-03) / 3 mL in 1 VIAL, GLASS
- ndc1161938456061 VIAL, GLASS in 1 CARTON (61938-456-06) / 6 mL in 1 VIAL, GLASS
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/aac37725-e45c-492a-a41a-e8fde2b997f0 GET /v1/drugs/aac37725-e45c-492a-a41a-e8fde2b997f0?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": "ENDOTRACHEAL",
"source": "ndc",
"strength": "35.7",
"substance": "CALFACTANT",
"productndc": "61938-456",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "BLA020521",
"marketing_category": "BLA"
}See everything about calfactant.
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.