haloperidol decanoate

In shortageOrange BookUNIISPLATC N05AD01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2502183405
1 VIAL in 1 CARTON (25021-834-05) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

AC20PJ4101

HALOPERIDOL DECANOATE

RxCUI 26420

Orange Book

A205241

AOAO

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Haloperidol Decanoate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "AC20PJ4101",
    "rxcui": "26420",
    "inchikey": "GUTXTARXLVFHDK-UHFFFAOYSA-N",
    "display_name": "HALOPERIDOL DECANOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "f9876b88-3caa-4c08-9a59-9b4a455e101d": {
      "match": "brand_token",
      "title": "HALOPERIDOL DECANOATE INJECTION [ARMAS PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "25021-834_62e2ca03-9545-4170-a750-d457aa2451a9",
  "productndc": "25021-834",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205241",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 12, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 100MG BASE/ML",
        "product_no": "002",
        "approval_date": "May 12, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOPERIDOL DECANOATE",
  "shortage_reason": "Haloperidol Decanoate Injection",
  "shortage_status": "current",
  "proprietary_name": "haloperidol decanoate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA205241",
  "marketing_category": "ANDA",
  "nonproprietary_name": "haloperidol decanoate",
  "start_marketing_date": "20171115",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code N05AD01.

Access this data programmatically

Query haloperidol decanoate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs