Haloperidol Decanoate

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerArmas Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7248552010
10 VIAL, SINGLE-DOSE in 1 CARTON (72485-520-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-520-01)

Annotations

UNII (FDA Substance ID)

AC20PJ4101

HALOPERIDOL DECANOATE

RxCUI 26420

Orange Book

A219168

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": "72485-520_f80ebd1c-e43e-4e6a-bbd0-96cfabafb548",
  "productndc": "72485-520",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219168",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 100MG BASE/ML",
        "product_no": "002",
        "approval_date": "May 13, 2025"
      }
    ],
    "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/mL",
  "application_number": "ANDA219168",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol Decanoate",
  "start_marketing_date": "20260515",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N05AD01.

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