Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965179001
100 TABLET in 1 BOTTLE (59651-790-01)
ndc11
5965179099
1000 TABLET in 1 BOTTLE (59651-790-99)

Annotations

UNII (FDA Substance ID)

J6292F8L3D

HALOPERIDOL

RxCUI 5093

Orange Book

A218789

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": "59651-790_265a70c4-9b29-464c-9258-735bd2b2ccf7",
  "productndc": "59651-790",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218789",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Apr 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Apr 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Apr 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Apr 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "Apr 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Apr 19, 2024"
      }
    ],
    "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": "ANDA218789",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol",
  "start_marketing_date": "20240419",
  "active_numerator_strength": "1"
}

Related drugs

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