United States· US:68462-802_b14164fb-0276-4ad1-a5ff-400ab9e292da
nintedanib
A medicinal product containing nintedanib esylate, registered in United States by Glenmark Pharmaceuticals Inc., USA.
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
- NINTEDANIB ESYLATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- 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
- ndc1168462-802-60
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Nintedanib esylate in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNINTEDANIB ACCORDAccord Healthcare S.L.U., Barcelona
- FinlandNintedanib AccordAccord Healthcare S.L.U.
- IrelandNintedanib Accord 100 mg soft capsulesAccord Healthcare S.L.U.
- BelgiumNintedanib Accord 100 mgAccord Healthcare
- GermanyNintedanib AlAliud Pharma Gmbh
- SwedenNintedanib Bioglan 100 mg Kapsel, mjukBioglan AB
- NorwayNintedanib ZentivaZentiva k.s.
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Nintedanib Accordpharma, Nintedanib Ratiopharm
- Cyprus · Nintedanib Teva
- Germany · Nintedanib Al, Nintedanib Ipf Al
- Denmark · Nintedanib Bioglan, Nintedanib Teva
- Estonia · Nintedanib Stada
- Finland · Bioglan, Nintedanib Bioglan
- United Kingdom (Northern Ireland) · Nintedanib, Nintedanib Eugia (Uk)
- Hungary · Lunidoc
- Iceland · Nintedanib Demo
- Luxembourg · Nintedanib Teva
- Netherlands · Nintedanib Reig Jofre, Nintedanib Tillomed
- Norway · Nintedanib Zentiva
- Portugal · Nintedanib Bravet, Nintedanib Teva Pharma
- Romania · Gevesla, Nintedanib Teva
- Sweden · Nintedanib Bioglan, Nintedanib Teva Gmbh
- Slovakia · Gevesla
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/20423949-50a1-4f39-8715-93d9b1c84ede GET /v1/drugs/20423949-50a1-4f39-8715-93d9b1c84ede?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": "100",
"substance": "NINTEDANIB ESYLATE",
"productndc": "68462-802",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA212555",
"marketing_category": "ANDA"
}See everything about nintedanib esylate.
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.