United States· US:68071-4500_1a8daeb9-2c25-ccc0-e063-6394a90a9cae
Terbinafine Hydrochloride
A medicinal product containing terbinafine hydrochloride, registered in United States by NuCare Pharmaceuticals,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
- TERBINAFINE HYDROCHLORIDE
- Manufacturer
- NuCare Pharmaceuticals,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 · 2
- ndc116807145001100 TABLET in 1 BOTTLE (68071-4500-1)
- ndc1168071-4500-1
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.
- United KingdomLamisil 250mg tabletsDE Pharmaceuticals
- FinlandFungorinOrion Corporation
- CzechiaLAMISILNovartis s.r.o., Praha
- FranceFUNGSTER 250 mg, comprimé sécablePIERRE FABRE MEDICAMENT
- SwitzerlandLamisil 250 mg, TablettenNovartis Pharma Schweiz AG
- ItalyLAMISILNOVARTIS FARMA S.P.A.
- SpainLAMISIL 250 mg COMPRIMIDOSNovartis Farmaceutica S.A.
- IrelandFungasil 250 mg tabletsClonmel Healthcare Ltd
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/e27cc2ec-4c3f-4917-a3f7-135abad17659 GET /v1/drugs/e27cc2ec-4c3f-4917-a3f7-135abad17659?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": "68071-4500",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA077714",
"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.