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United States · US · US:0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c
Haloperidol
In shortageOrange BookUNIISPLATC N05AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN05AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110121058104120 mL in 1 BOTTLE (0121-0581-04)
- ndc11012105810510 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
- ndc11012105811515 mL in 1 BOTTLE (0121-0581-15)
Annotations
UNII (FDA Substance ID)
J6292F8L3D
HALOPERIDOL
RxCUI 5093
Orange Book
A073037
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Haloperidol Decanoate Injection
Raw payload (JSON)
{
"unii": {
"unii": "J6292F8L3D",
"rxcui": "5093",
"inchikey": "LNEPOXFFQSENCJ-UHFFFAOYSA-N",
"display_name": "HALOPERIDOL",
"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": "0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c",
"productndc": "0121-0581",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "073037",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "EQ 2MG BASE/ML",
"product_no": "001",
"approval_date": "Feb 26, 1993"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HALOPERIDOL",
"shortage_reason": "Haloperidol Decanoate Injection",
"shortage_status": "current",
"proprietary_name": "Haloperidol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA073037",
"marketing_category": "ANDA",
"nonproprietary_name": "Haloperidol",
"start_marketing_date": "20091110",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05AD01.
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