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United States · US · US:0143-9501_7b501c8b-902c-47ef-86e6-00c295473fd6
Haloperidol
In shortageOrange BookUNIISPLATC N05AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014395012525 VIAL in 1 BOX (0143-9501-25) / 1 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
6387S86PK3
HALOPERIDOL LACTATE
RxCUI 217483
Orange Book
A075858
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": "0143-9501_7b501c8b-902c-47ef-86e6-00c295473fd6",
"productndc": "0143-9501",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "075858",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Jun 18, 2001"
}
],
"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": "ANDA075858",
"marketing_category": "ANDA",
"nonproprietary_name": "Haloperidol lactate",
"start_marketing_date": "20010619",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AD01.
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