United States· US:68546-317_11a58ba0-b865-49e6-86e3-eb9bb58341e5
Copaxone
A medicinal product containing glatiramer acetate, registered in United States by Teva Neuroscience, 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
- GLATIRAMER ACETATE
- Manufacturer
- Teva Neuroscience, 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
- ndc1168546-317-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Glatiramer acetate in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandBrabio 20 mg/ml solution for injection, pre-filled syringeViatris Limited
- SwedenCopaxone 20 mg/ml Injektionsvätska, lösning i förfylld sprutaOrifarm AB
- CzechiaCOPAXONETeva Pharmaceuticals CR, s.r.o., Praha
- GermanyCliftViatris Germany Gmbh
- BelgiumCopaxone 20 mg/mlTeva
- FinlandCopaxoneTeva GmbH
- NorwayCopaxoneTeva GmbH
- CanadaCOPAXONETEVA CANADA LIMITED
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Copaxone, Perscleran
- Belgium · Copaxone, Glataxon
- Bulgaria · Копаксон, Ремурел
- Cyprus · Clift, Copaxone
- Czechia · Copaxone, Remurel
- Germany · Clift, Copaxone
- Denmark · Copaxone, Copemyl
- Estonia · Copaxone, Remurel
- Spain · Copaxone, Glatiramero Viatris
- Finland · Copaxone, Glatimyl
- France · Copaxone, Copaxone Pen
- United Kingdom (Northern Ireland) · Brabio, Copaxone
- Greece · Clift, Copaxone
- Croatia · Copaxone, Remurel
- Hungary · Copaxone, Remurel
- Ireland · Brabio, Copaxone
- Iceland · Copaxone, Remurel
- Italy · Copaxone, Copemyl
- Lithuania · Copaxone, Remurel
- Luxembourg · Copaxone, Copaxone Pen
- Latvia · Copaxone, Remurel
- Malta · Galtipex
- Netherlands · Brabio, Copaxone
- Norway · Copaxone, Copemyl
- Poland · Copaxone, Remurel
- Portugal · Acetato De Glatirâmero Viatris, Clift
- Romania · Copaxone, Remurel
- Sweden · Copaxone, Glatimyl
- Slovenia · Copaxone, Remurel
- Slovakia · Copaxone, Copaxone Teva
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/7b305757-c20f-48cc-9341-b37ef8c5cdab GET /v1/drugs/7b305757-c20f-48cc-9341-b37ef8c5cdab?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": "20",
"substance": "GLATIRAMER ACETATE",
"productndc": "68546-317",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA020622",
"marketing_category": "NDA"
}See everything about glatiramer acetate.
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.