United States· US:0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538

VIGADRONE

A medicinal product containing vigabatrin, registered in United States by Upsher-Smith Laboratories, LLC.

US 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…normalisedVIGADRONEATC—REGISTER NO.US:0245-0556_3aae9c74…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
vigabatrin
Manufacturer
Upsher-Smith Laboratories, LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    0245055650
    50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Vigabatrin in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All vigabatrin products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Sabril
  • Belgium · Sabril
  • Czechia · Sabril
  • Germany · Sabril, Sabril Beutel
  • Denmark · Sabrilex
  • Spain · Sabrilex, Vigzip
  • Finland · Sabrilex
  • France · Sabril, Vigzip
  • United Kingdom (Northern Ireland) · Sabril, Vigabatrin Zydus Pharmaceuticals Uk
  • Greece · Sabril
  • Hungary · Sabril
  • Ireland · Sabril
  • Iceland · Kigabeq, Sabrilex
  • Italy · Sabril, Vigzip
  • Liechtenstein · Kigabeq
  • Luxembourg · Sabril
  • Netherlands · Sabril, Sabril Filmomhulde Tablet
  • Norway · Kigabeq, Sabrilex
  • Poland · Sabril
  • Portugal · Sabril
  • Sweden · Sabrilex
  • Slovenia · Sabril
  • Slovakia · Sabril

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/f23035c8-561c-435b-980e-79034b5dcfa7
GET /v1/drugs/f23035c8-561c-435b-980e-79034b5dcfa7?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",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 4
  },
  "productid": "0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538",
  "productndc": "0245-0556",
  "dosage_form": "POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VIGABATRIN",
  "proprietary_name": "VIGADRONE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "vigabatrin",
  "start_marketing_date": "20180621",
  "active_numerator_strength": "50"
}

See everything about vigabatrin.

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.