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United States· US:43353-124_66435209-390b-4344-9b5b-47c9c2d92e2f

Hydralazine Hydrochloride

A hydralazine product containing hydralazine hydrochloride, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 6 of our 19 countries.

ATC C02DB02US 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…normalisedHydralazine HydrochlorideATCC02DB02REGISTER NO.US:43353-124_66435209…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about hydralazine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Hydralazine is registered in 6 of 19 countries.

Countries holding a registration under ATC C02DB02 (hydralazine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 3 of them publish a price we can compare per daily dose
Search hydralazine products by name

Hydralazine · ATC C02DB02

6 / 19 countries

  • Canada
  • Finlandprice
  • Japan
  • Norwayprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HYDRALAZINE HYDROCHLORIDE
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Country
United States (US)
ATC code
C02DB02
ATC class
Hydralazine
Defined daily dose
0.1 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    43353-124-05
  • ndc11
    4335312405
    4200 TABLET in 1 BOTTLE (43353-124-05)

Regulatory notes

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

Interactions

163 interactions on record for hydralazine.

Graded by severity as the source publishes them — 145 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check hydralazine against other medicinesHow interaction checks work

Hydralazine · interactions on record

163 records

  • 145 moderate
  • 1 minor
  • 17 info

Most severe, free to view

  • ThiethylperazinA04AB03moderate
  • DiphenhydraminA04AB05moderate
  • DronabinolA04AD10moderate
  • NabiloneA04AD11moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Hydralazine in 5 other countries

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

All hydralazine products

Authorised across Europe · EMA

The same active substance is authorised in 6 EEA countries. Names it is sold under:

  • Cyprus · Hydralazine Remedica
  • Spain · Hydrapres
  • United Kingdom (Northern Ireland) · Apresoline, Hydralazine Accord-Uk
  • Malta · Hydralazine Remedica
  • Norway · Apresolin
  • Sweden · Apresolin

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/edf7773e-ec4d-479a-9396-17e810df167c
GET /v1/drugs/edf7773e-ec4d-479a-9396-17e810df167c?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": "100",
  "substance": "HYDRALAZINE HYDROCHLORIDE",
  "productndc": "43353-124",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA089098",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about hydralazine.

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.

Try it freeOpen in the console