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United States· US:71288-503_2cbc95d6-a15f-431f-9ff0-4827251bb767

Haloperidol Decanoate

A medicinal product containing haloperidol decanoate, registered in United States by Meitheal Pharmaceuticals Inc..

US 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…normalisedHaloperidol DecanoateATC—REGISTER NO.US:71288-503_2cbc95d6…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HALOPERIDOL DECANOATE
Manufacturer
Meitheal Pharmaceuticals Inc.
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 · 2

  • ndc11
    7128850302
    10 VIAL, SINGLE-DOSE in 1 CARTON (71288-503-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-503-01)
  • ndc11
    71288-503-02

Regulatory notes

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

Same medicine, other countries

Haloperidol decanoate in 7 other countries

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

All haloperidol decanoate products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Austria · Haldol Decanoat, Haloperidol Hikma
  • Belgium · Haldol Decanoas
  • Cyprus · Haldol Decanoas
  • Germany · Haldol Depot, Haldol-Depot
  • Denmark · Serenase Dekanoat
  • Finland · Serenase Depot
  • France · Haldol Decanoas, Haloperidol Lp Hikma
  • United Kingdom (Northern Ireland) · Haldol Decanoate, Haloperidol Depot Hikma
  • Greece · Aloperidin Decanoas
  • Ireland · Haldol Decanoate
  • Iceland · Haldol Depot
  • Italy · Aloperidolo Hikma, Haldol Decanoas
  • Liechtenstein · Haldol Decanoas
  • Lithuania · Haloperidol Decanoate Richter
  • Luxembourg · Haldol Decanoas
  • Malta · Haldol Decanoate
  • Netherlands · Haldol Decanoas, Haloperidol Hikma
  • Norway · Haldol Depot
  • Poland · Decaldol
  • Portugal · Haldol Decanoato, Haloperidol Hikma
  • Sweden · Haldol Depot

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/d19a4c68-f066-4ef3-b3fe-bf84e312537f
GET /v1/drugs/d19a4c68-f066-4ef3-b3fe-bf84e312537f?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",
  "source": "ndc",
  "strength": "100",
  "substance": "HALOPERIDOL DECANOATE",
  "productndc": "71288-503",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA214507",
  "marketing_category": "ANDA"
}

See everything about haloperidol decanoate.

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.