United States· US:44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48
Tinidazole
A medicinal product containing tinidazole, registered in United States by BioComp Pharma, 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
- TINIDAZOLE
- Manufacturer
- BioComp Pharma, 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 · 4
- ndc11445234501212 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)
- ndc11445234502020 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)
- ndc1144523-450-12
- ndc1144523-450-20
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tinidazole in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumFasigyn 500 mgPfizer
- PolandTinidazolum PolpharmaZakłady Farmaceutyczne POLPHARMA S.A.
- FinlandTricanixOrion Corporation Orion Pharma
- United KingdomFasigyn 500mg tabletsSigma Pharmaceuticals Plc
- FranceFASIGYNE 500 mg, comprimé enrobéTEOFARMA
- NorwayFasigyneTeofarma
- SpainTRICOLAM COMPRIMIDOSFarmasierra Laboratorios S.L.
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Bulgaria · Тинидазол Актавис
- Cyprus · Tinirem
- Spain · Tricolam
- France · Fasigyne
- Italy · Trimonase
- Poland · Tinidazolum Polpharma
- Romania · Tinizol, Tiprogyn
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/c2733b21-8118-4170-9845-64c11ee11a07 GET /v1/drugs/c2733b21-8118-4170-9845-64c11ee11a07?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": "500",
"substance": "TINIDAZOLE",
"productndc": "44523-450",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA021618",
"marketing_category": "NDA AUTHORIZED GENERIC"
}See everything about tinidazole.
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.