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United States · US · US:67457-426_78868903-4ca8-4da0-84bc-340726c9ea4e
HALOPERIDOL LACTATE
In shortageOrange BookUNIISPLATC N05AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeN05AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11674574261225 VIAL in 1 CARTON (67457-426-12) / 1 mL in 1 VIAL (67457-426-00)
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": "67457-426_78868903-4ca8-4da0-84bc-340726c9ea4e",
"productndc": "67457-426",
"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": "20141218",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AD01.
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