Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068716101
100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-161-01) / 1 TABLET in 1 BLISTER PACK (60687-161-11)

Annotations

UNII (FDA Substance ID)

J6292F8L3D

HALOPERIDOL

RxCUI 5093

Orange Book

A077580

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": "60687-161_37b4ce85-4549-d7a7-e063-6294a90ac1ee",
  "productndc": "60687-161",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077580",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Jan 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jan 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Nov 29, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Nov 29, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Nov 29, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "006",
        "approval_date": "Jan 17, 2023"
      }
    ],
    "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": "ANDA077580",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol",
  "start_marketing_date": "20160309",
  "active_numerator_strength": "5"
}

Related drugs

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