United States· US:0781-3250_104fa47b-517a-44aa-9308-55c97679540b

Glatopa

A medicinal product containing glatiramer acetate, registered in United States by Sandoz Inc.

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedGlatopaATC—REGISTER NO.US:0781-3250_104fa47b…PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GLATIRAMER ACETATE
Manufacturer
Sandoz 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

  • ndc11
    0781-3250-89

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.

All glatiramer acetate products

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/b96ad886-38ab-47ab-86c9-83b95d53e9a5
GET /v1/drugs/b96ad886-38ab-47ab-86c9-83b95d53e9a5?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": "40",
  "substance": "GLATIRAMER ACETATE",
  "productndc": "0781-3250",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA206921",
  "marketing_category": "ANDA"
}

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.