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United States · US · US:55154-7076_11dd6850-9fda-4f26-b107-3f242d7a0d35

HALOPERIDOL LACTATE

In shortageOrange BookUNIISPLATC N05AD01

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeN05AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515470765
    5 VIAL in 1 BAG (55154-7076-5) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
6387S86PK3
HALOPERIDOL LACTATE
RxCUI 217483
Orange Book
A078347
AP
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": "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": "55154-7076_11dd6850-9fda-4f26-b107-3f242d7a0d35",
  "productndc": "55154-7076",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078347",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 14, 2009"
      }
    ],
    "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 LACTATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078347",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HALOPERIDOL LACTATE",
  "start_marketing_date": "20110510",
  "active_numerator_strength": "5"
}

Related drugs

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