United States· US:55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1

Hydralazine Hydrochloride

A hydralazine product containing hydralazine hydrochloride, registered in United States by Cardinal Health 107, LLC. The same ATC class is registered in 6 of our 19 countries.

ATC C02DB02Orange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about hydralazine hydrochlorideAnswers with sources · free account Check 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: Cardinal Health 107, 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 12, 2026

Packs & prices · 1

ndc11
5515495545
5 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5) / 1 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)

FD171B778Y

HYDRALAZINE HYDROCHLORIDE

RxCUI 82027

Orange Book

A040388

DailyMed SPL labels

1 version tracked

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 medicines How 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/b284ff25-b89b-4cbf-88d4-033fe2a835d8
GET /v1/drugs/b284ff25-b89b-4cbf-88d4-033fe2a835d8?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.

{
  "unii": {
    "unii": "FD171B778Y",
    "rxcui": "82027",
    "inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
    "display_name": "HYDRALAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 1
  },
  "spl_meta": {
    "a1066707-2391-4918-8ded-600c017fde48": {
      "match": "brand_token",
      "title": "HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1",
  "productndc": "55154-9554",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "040388",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Mar 13, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE",
  "proprietary_name": "Hydralazine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040388",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HYDRALAZINE HYDROCHLORIDE",
  "start_marketing_date": "20010905",
  "active_numerator_strength": "20"
}

API reference MCP server Plans

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.

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