United States· US:65145-169_4f9af14a-38c4-4826-aca0-3501edb854e3
Haloperidol Decanoate
A medicinal product containing haloperidol decanoate, registered in United States by Caplin Steriles Limited.
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
- HALOPERIDOL DECANOATE
- Manufacturer
- Caplin Steriles Limited
- 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
- ndc1165145-169-01
- ndc1165145169011 VIAL, MULTI-DOSE in 1 CARTON (65145-169-01) / 5 mL in 1 VIAL, MULTI-DOSE
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.
- SwedenHaldol Depot 100 mg/ml Injektionsvätska, lösningEssential Pharma Ltd
- GermanyHaldol DepotEssential Pharma Limited
- BelgiumHaldol Decanoas 100 mg/mlEssential Pharma
- FinlandSerenase DepotEssential Pharma Ltd
- United KingdomHaldol Decanoate 100mg/1ml solution for injection ampoulesDrugsrus Ltd
- IrelandHaldol Decanoate 100 mg/ml Solution for InjectionEssential Pharma Limited
- NorwayHaldol DepotEssential Pharma Limited
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/ab474497-d812-42cb-8ad8-074901765f3b GET /v1/drugs/ab474497-d812-42cb-8ad8-074901765f3b?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": "65145-169",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA219168",
"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.