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United States · US · US:70756-004_7b545974-2d39-4106-8975-76c124a6c5ee

Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerLifestar Pharma LLC
CountryUS (United States)
ATC codeN05AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7075600411
    100 TABLET in 1 BOTTLE (70756-004-11)
  • ndc11
    7075600412
    1000 TABLET in 1 BOTTLE (70756-004-12)

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": "70756-004_7b545974-2d39-4106-8975-76c124a6c5ee",
  "productndc": "70756-004",
  "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": "20240411",
  "active_numerator_strength": "5"
}

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