Haldol Decanoate

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5045825414
5 AMPULE in 1 BOX (50458-254-14) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

AC20PJ4101

HALOPERIDOL DECANOATE

RxCUI 26420

Orange Book

N018701

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": {
    "af0159a8-dff5-449a-aa2b-a0c430081e21": {
      "match": "brand_token",
      "title": "HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "25",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50458-254_43588a6b-8b38-dcaa-e063-6294a90a1666",
  "productndc": "50458-254",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018701",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 14, 1986"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jan 31, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOPERIDOL DECANOATE",
  "shortage_reason": "Haloperidol Decanoate Injection",
  "shortage_status": "current",
  "proprietary_name": "Haldol Decanoate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018701",
  "marketing_category": "NDA",
  "nonproprietary_name": "Haloperidol Decanoate",
  "start_marketing_date": "19860114",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N05AD01.

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