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United States· US:68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807

Procainamide Hydrochloride

A procainamide product containing procainamide hydrochloride, registered in United States by Gland Pharma Limited. The same ATC class is registered in 5 of our 19 countries.

ATC C01BA02US 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…normalisedProcainamide HydrochlorideATCC01BA02REGISTER NO.US:68083-604_e8e25e4b…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Procainamide is registered in 5 of 19 countries.

Countries holding a registration under ATC C01BA02 (procainamide), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Procainamide · ATC C01BA02

5 / 19 countries

  • Canada
  • Finlandprice
  • Japan
  • 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
PROCAINAMIDE HYDROCHLORIDE
Manufacturer
Gland Pharma Limited
Country
United States (US)
ATC code
C01BA02
ATC class
Procainamide
Defined daily dose
3 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
    6808360425
    25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    68083-604-25

Regulatory notes

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

Interactions

236 interactions on record for procainamide.

Graded by severity as the source publishes them — 138 severe. 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

Procainamide · interactions on record

236 records

  • 138 severe
  • 85 moderate
  • 8 minor
  • 4 info

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Procainamide in 3 other countries

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

All procainamide products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Spain · Biocoryl

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/b497ac58-e78a-4fab-8f71-3ac2aa4d0f89
GET /v1/drugs/b497ac58-e78a-4fab-8f71-3ac2aa4d0f89?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": "INTRAMUSCULAR; INTRAVENOUS",
  "source": "ndc",
  "strength": "500",
  "substance": "PROCAINAMIDE HYDROCHLORIDE",
  "productndc": "68083-604",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA218135",
  "marketing_category": "ANDA"
}

See everything about procainamide.

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.