United States· US:61269-380_9ae4b955-4845-4b4c-bb9e-492e7c8e516f
PYLERA
A bismuth subcitrate, tetracycline and metronidazole product containing bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride, registered in United States by H2-Pharma, LLC. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Bismuth subcitrate, tetracycline and metronidazole is registered in 9 of 19 countries.
Countries holding a registration under ATC A02BD08 (bismuth subcitrate, tetracycline and metronidazole), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Bismuth subcitrate, tetracycline and metronidazole · ATC A02BD08
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
- Manufacturer
- H2-Pharma, LLC
- Country
- United States (US)
- ATC code
- A02BD08
- ATC class
- Bismuth subcitrate, tetracycline and metronidazole
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1161269-380-12
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bismuth subcitrate, tetracycline and metronidazole in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandPyleraProcareplus Pharma S.A.
- CzechiaPYLERALaboratoires Juvisé Pharmaceuticals, Villeurbanne
- GermanyPyleraLaboratoires Juvise Pharmaceuticals
- FinlandPyleraLaboratoires Juvise Pharmaceuticals
- SwitzerlandPylera 140 mg/125 mg/125 mg, HartkapselnMedius AG
- IrelandPylera 140 mg/125 mg/125 mg capsules, hardLaboratoires Juvise Pharmaceuticals
- SwedenPylera 140 mg/125 mg/125 mg Kapsel, hårdLaboratoires Juvise Pharmaceuticals
- FrancePYLERA 140 mg/125 mg/125 mg, géluleLABORATOIRES JUVISE PHARMACEUTICALS
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Pylera
- Belgium · Tryplera
- Bulgaria · Pylera
- Czechia · Pylera
- Germany · Pylera
- Denmark · Pylera
- Estonia · Pylera
- Spain · Pylera
- Finland · Pylera
- France · Pylera
- United Kingdom (Northern Ireland) · Pylera
- Ireland · Pylera
- Italy · Pylera
- Lithuania · Pylera
- Luxembourg · Tryplera
- Latvia · Pylera
- Malta · Pylera
- Norway · Pylera
- Poland · Pylera
- Portugal · Pylera
- Romania · Pylera
- Sweden · Pylera
- Slovakia · Pylera
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/d58f527c-61af-46ec-adf8-5bfc82536da0 GET /v1/drugs/d58f527c-61af-46ec-adf8-5bfc82536da0?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": "140; 125; 125",
"substance": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
"productndc": "61269-380",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA050786",
"marketing_category": "NDA"
}See everything about bismuth subcitrate, tetracycline and metronidazole.
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.