United States· US:71610-503_b23a32b3-7e6b-4b58-be96-303ac3ef069a
Terazosin
A medicinal product containing terazosin hydrochloride, registered in United States by Aphena Pharma Solutions - Tennessee, LLC.
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
- TERAZOSIN HYDROCHLORIDE
- Manufacturer
- Aphena Pharma Solutions - Tennessee, 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 27, 2026
Packs & prices · 4
- ndc1171610-503-60
- ndc1171610-503-80
- ndc11716105036090 CAPSULE in 1 BOTTLE (71610-503-60)
- ndc117161050380180 CAPSULE in 1 BOTTLE (71610-503-80)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Terazosin hydrochloride in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBenph 2mg tabletsViatris UK Healthcare Ltd
- ItalyITRINEBERLIFE FARMACEUTICI S.P.A.
- BelgiumHytrin 1 mgAmdipharm
- SpainALFAPROST 5 mg COMPRIMIDOSBiowise Pharmaceuticals, S.L.
- CanadaAPO-TERAZOSINAPOTEX INC
- NetherlandsHytrin 10, tabletten 10 mgAmdipharm Limited
- FranceDYSALFA 1 mg, compriméAMDIPHARM
- NorwayHeitrinAmdipharm
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Uroflo, Vicard
- Belgium · Hytrin, Terazosab
- Czechia · Kornam
- Germany · Heitrin, Tera Tad
- Denmark · Sinalfa
- Spain · Alfaprost, Mayul
- France · Dysalfa, Hytrine
- United Kingdom (Northern Ireland) · Hytrin, Terazosin
- Greece · Hytrin
- Hungary · Setegis
- Ireland · Hytrin
- Italy · Itrin, Prostatil
- Luxembourg · Hytrin, Terazosab
- Netherlands · Hytrin, Terazosine Accord
- Norway · Sinalfa
- Poland · Hytrin, Kornam
- Portugal · Hytrin
- Sweden · Sinalfa
- Slovenia · Kornam
- Slovakia · Kornam
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/f56c4a11-9f22-442f-bb3d-70290197c615 GET /v1/drugs/f56c4a11-9f22-442f-bb3d-70290197c615?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": "5",
"substance": "TERAZOSIN HYDROCHLORIDE",
"productndc": "71610-503",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA075317",
"marketing_category": "ANDA"
}See everything about terazosin 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.