Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN05AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051842850
30 TABLET in 1 BLISTER PACK (70518-4285-0)

Annotations

UNII (FDA Substance ID)

J6292F8L3D

HALOPERIDOL

RxCUI 5093

Orange Book

A216918

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": "70518-4285_401b5d09-1bca-e6e0-e063-6294a90a2a0a",
  "productndc": "70518-4285",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216918",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Apr 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "Apr 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Apr 11, 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": "ANDA216918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "haloperidol",
  "start_marketing_date": "20250211",
  "active_numerator_strength": "5"
}

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