United States· US:72606-047_e81d34f1-0902-43ef-ab88-470bcc6c0544
ZYMFENTRA
A medicinal product containing infliximab-dyyb, registered in United States by CELLTRION USA 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
- INFLIXIMAB-DYYB
- Manufacturer
- CELLTRION USA 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 · 1
- ndc1172606-047-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Infliximab-dyyb in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaFLIXABISamsung Bioepis NL B.V., Delft
- SwitzerlandFlixabi
- FinlandFlixabiSAMSUNG BIOEPIS NL B.V.
- BelgiumFlixabi 100 mgSamsung Bioepis NL
- SpainFLIXABI 100MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONSamsung Bioepis Nl B.V.
- PolandFlixabiSamsung Bioepis NL B.V.
- IrelandFlixabi 100 mg powder for concentrate for solution for infusionSamsung Bioepis NL B.V.
- IcelandFlixabiSamsung Bioepis NL B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Remicade, Remsima
- Liechtenstein · Remicade, Remsima
- Norway · Remicade, Remsima
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/a6b0d387-32b0-4f65-8bd1-f83ce8ef3162 GET /v1/drugs/a6b0d387-32b0-4f65-8bd1-f83ce8ef3162?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": "SUBCUTANEOUS",
"source": "ndc",
"strength": "120",
"substance": "INFLIXIMAB-DYYB",
"productndc": "72606-047",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "BLA761358",
"marketing_category": "BLA"
}See everything about infliximab-dyyb.
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.