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United States · US · US:70756-615_bae2fb28-774a-44e2-89ed-4412e71f98ec

Haloperidol Decanoate

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 · 3

  • ndc11
    7075661510
    10 VIAL in 1 CARTON (70756-615-10) / 1 mL in 1 VIAL
  • ndc11
    7075661533
    3 VIAL in 1 CARTON (70756-615-33) / 1 mL in 1 VIAL
  • ndc11
    7075661581
    1 VIAL in 1 CARTON (70756-615-81) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
AC20PJ4101
HALOPERIDOL DECANOATE
RxCUI 26420
Orange Book
A216730
AOAO
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Haloperidol Decanoate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "AC20PJ4101",
    "rxcui": "26420",
    "inchikey": "GUTXTARXLVFHDK-UHFFFAOYSA-N",
    "display_name": "HALOPERIDOL DECANOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "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": "70756-615_bae2fb28-774a-44e2-89ed-4412e71f98ec",
  "productndc": "70756-615",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216730",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 23, 2023"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AO",
        "strength": "EQ 100MG BASE/ML",
        "product_no": "002",
        "approval_date": "May 23, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOPERIDOL DECANOATE",
  "shortage_reason": "Haloperidol Decanoate Injection",
  "shortage_status": "current",
  "proprietary_name": "Haloperidol Decanoate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216730",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol Decanoate",
  "start_marketing_date": "20230523",
  "active_numerator_strength": "50"
}

Related drugs

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