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United States · US · US:54838-501_898ee841-bdf7-4306-ac5c-282e522afd9f

Haloperidol

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN05AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5483850115
    15 mL in 1 BOTTLE, DROPPER (54838-501-15)
  • ndc11
    5483850140
    120 mL in 1 BOTTLE, DROPPER (54838-501-40)

Annotations

UNII (FDA Substance ID)
6387S86PK3
HALOPERIDOL LACTATE
RxCUI 217483
Orange Book
A073364
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Haloperidol Decanoate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "6387S86PK3",
    "rxcui": "217483",
    "inchikey": "BVUSNQJCSYDJJG-UHFFFAOYSA-N",
    "display_name": "HALOPERIDOL LACTATE",
    "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": "54838-501_898ee841-bdf7-4306-ac5c-282e522afd9f",
  "productndc": "54838-501",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "073364",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 2MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 28, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HALOPERIDOL LACTATE",
  "shortage_reason": "Haloperidol Decanoate Injection",
  "shortage_status": "current",
  "proprietary_name": "Haloperidol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA073364",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Haloperidol",
  "start_marketing_date": "19930928",
  "active_numerator_strength": "2"
}

Related drugs

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