United States· US:68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb

Copaxone

A glatiramer acetate product containing glatiramer acetate, registered in United States by Teva Neuroscience, Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC L03AX13Orange BookUS label

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedCopaxoneATCL03AX13REGISTER NO.US:68546-325_5a691b1f…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Glatiramer acetate is registered in 14 of 19 countries.

Countries holding a registration under ATC L03AX13 (glatiramer acetate), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 10 of them publish a price we can compare per daily dose

Glatiramer acetate · ATC L03AX13

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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
L03AX13
ATC class
Glatiramer acetate
Defined daily dose
20 mg, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    6854632506
    6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
  • ndc11
    6854632512
    12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

Regulatory notes

UNII (FDA substance ID)
5M691HL4BO
GLATIRAMER ACETATE
RxCUI 84375
Orange Book
N020622
APAP
DailyMed SPL labels
1 version tracked

Interactions

2 interactions on record for glatiramer acetate.

Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Glatiramer acetate · interactions on record

2 records

  • 2 severe

Most severe, free to view

  • NatalizumabL04AA23severe
  • NatalizumabL04AG03severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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/d51f1220-cab8-4867-9e3f-a518410aa5b3
GET /v1/drugs/d51f1220-cab8-4867-9e3f-a518410aa5b3?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.

{
  "unii": {
    "unii": "5M691HL4BO",
    "rxcui": "84375",
    "inchikey": null,
    "display_name": "GLATIRAMER ACETATE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 2
  },
  "spl_meta": {
    "aa88f583-4f5f-433b-80b4-1f4c9fb28357": {
      "match": "brand_token",
      "title": "COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.]",
      "spl_version": "35",
      "published_date": "2025-02-21"
    }
  },
  "productid": "68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb",
  "productndc": "68546-325",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020622",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 20, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "002",
        "approval_date": "Feb 12, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/ML",
        "product_no": "003",
        "approval_date": "Jan 28, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLATIRAMER ACETATE",
  "proprietary_name": "Copaxone",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020622",
  "marketing_category": "NDA",
  "nonproprietary_name": "Glatiramer Acetate",
  "start_marketing_date": "20140129",
  "active_numerator_strength": "40"
}

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.