Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278956801
100 TABLET in 1 BOTTLE, PLASTIC (72789-568-01)

Annotations

UNII (FDA Substance ID)

J6292F8L3D

HALOPERIDOL

RxCUI 5093

Orange Book

A071130

ABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Haloperidol Decanoate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "J6292F8L3D",
    "rxcui": "5093",
    "inchikey": "LNEPOXFFQSENCJ-UHFFFAOYSA-N",
    "display_name": "HALOPERIDOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "72789-568_50221596-087a-9973-e063-6394a90ae95f",
  "productndc": "72789-568",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071130",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Feb 17, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 17, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 12, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "004",
        "approval_date": "Apr 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "005",
        "approval_date": "Apr 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Apr 8, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOPERIDOL",
  "shortage_reason": "Haloperidol Decanoate Injection",
  "shortage_status": "current",
  "proprietary_name": "Haloperidol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071130",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol",
  "start_marketing_date": "20260408",
  "active_numerator_strength": "2"
}

Related drugs

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