United States· US:75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa
TEPEZZA
A medicinal product containing teprotumumab, registered in United States by Horizon Therapeutics 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
- TEPROTUMUMAB
- Manufacturer
- Horizon Therapeutics 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
- June 26, 2026
Packs & prices · 2
- ndc1175987130151 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
- ndc1175987-130-15
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Teprotumumab in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumTepezza 500 mgAmgen Europe
- SwitzerlandTepezza 500 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungAmgen Switzerland AG
- CzechiaTEPEZZAAmgen Europe B.V., Breda
- SpainTEPEZZA 500 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONAmgen Europe B.V.
- FinlandTEPEZZAAmgen Europe B.V.
- FranceTEPEZZA 500 mg, poudre pour solution à diluer pour perfusionAMGEN EUROPE
- United KingdomTepezza 500mg powder for concentrate for solution for infusion vialsAmgen Ltd
- IrelandTEPEZZA 500 mg powder for concentrate for solution for infusionAmgen Europe B.V.,
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Iceland · Tepezza
- Norway · Tepezza
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/60a32ed9-5197-41bc-88ac-ad8c41c94075 GET /v1/drugs/60a32ed9-5197-41bc-88ac-ad8c41c94075?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": "500",
"substance": "TEPROTUMUMAB",
"productndc": "75987-130",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "BLA761143",
"marketing_category": "BLA"
}See everything about teprotumumab.
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.