United States· US:71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f

Terbinafine

A medicinal product containing terbinafine hydrochloride, registered in United States by Proficient Rx LP.

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…normalisedTerbinafineATC—REGISTER NO.US:71205-492_bfd48470…PACKS LISTED12CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TERBINAFINE HYDROCHLORIDE
Manufacturer
Proficient Rx LP
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 · 12

  • ndc11
    7120549230
    30 TABLET in 1 BOTTLE (71205-492-30)
  • ndc11
    7120549235
    35 TABLET in 1 BOTTLE (71205-492-35)
  • ndc11
    7120549242
    42 TABLET in 1 BOTTLE (71205-492-42)
  • ndc11
    7120549245
    45 TABLET in 1 BOTTLE (71205-492-45)
  • ndc11
    7120549260
    60 TABLET in 1 BOTTLE (71205-492-60)
  • ndc11
    7120549290
    90 TABLET in 1 BOTTLE (71205-492-90)
  • ndc11
    71205-492-30
  • ndc11
    71205-492-35
  • ndc11
    71205-492-42
  • ndc11
    71205-492-45
  • ndc11
    71205-492-60
  • ndc11
    71205-492-90

Regulatory notes

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

Same medicine, other countries

Terbinafine hydrochloride in 16 other countries

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

All terbinafine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Amykal, Lamisil
  • Belgium · Lamisil, Lamisil Dermgel
  • Bulgaria · Exoterbyn, Ербинол
  • Cyprus · Chemiderm, Chemiderm Τοπικό Αντιμυκnτιασικό Φάρμακο
  • Czechia · Lamisil, Terbinafin Actavis
  • Germany · Fungizid Extra, Lamisil
  • Denmark · Finigen, Lamisil
  • Estonia · Exotafin, Lamisil
  • Spain · Lamisil, Pevaryl Uñas
  • Finland · Fungorin, Lamisil
  • France · Fungster, Lamisil
  • United Kingdom (Northern Ireland) · Boots Athlete's Foot, Lamisil
  • Greece · Anaplas, Chemiderm
  • Croatia · Atere, Exoterbyn
  • Hungary · Exoterbyn, Lamisil Derma
  • Ireland · Fungasil, Lamisil
  • Iceland · Lamisil, Lamisil Once
  • Italy · Lamisil, Micutan
  • Lithuania · Lamisil, Lamisil Dermgel
  • Luxembourg · Lamisil, Lamisil Dermgel
  • Latvia · Exotafin, Lamisil
  • Malta · Fungasil, Fungasil 250mg Tablets
  • Netherlands · Antischimmelcrème Terbinafine Hcl Htp, Binanidda
  • Norway · Lamisil, Lamisil Dermgel
  • Poland · Erfin, Lamisilatt
  • Portugal · Fungur, Lamisil
  • Romania · Exoterfyn, Fungisil Mk
  • Sweden · Azurifin, Lamisil
  • Slovenia · Exoter, Lamisil
  • Slovakia · Exoterin, Lamisil

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/1e6f354d-4498-4a97-b3b3-eb3ad318a3ba
GET /v1/drugs/1e6f354d-4498-4a97-b3b3-eb3ad318a3ba?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",
  "source": "ndc",
  "strength": "250",
  "substance": "TERBINAFINE HYDROCHLORIDE",
  "productndc": "71205-492",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA078297",
  "marketing_category": "ANDA"
}

See everything about terbinafine hydrochloride.

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.