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United States · US · US:63323-471_86dff2aa-2ab3-42fc-989e-619b13ace573
Haloperidol Decanoate
In shortageOrange BookUNIISPLATC N05AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN05AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163323471011 VIAL in 1 CARTON (63323-471-01) / 1 mL in 1 VIAL
- ndc1163323471051 VIAL, MULTI-DOSE in 1 CARTON (63323-471-05) / 5 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
AC20PJ4101
HALOPERIDOL DECANOATE
RxCUI 26420
Orange Book
A074893
AOAO
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Haloperidol Decanoate Injection
Raw payload (JSON)
{
"unii": {
"unii": "AC20PJ4101",
"rxcui": "26420",
"inchikey": "GUTXTARXLVFHDK-UHFFFAOYSA-N",
"display_name": "HALOPERIDOL DECANOATE",
"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": "63323-471_86dff2aa-2ab3-42fc-989e-619b13ace573",
"productndc": "63323-471",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "074893",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "EQ 50MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 19, 1997"
},
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "EQ 100MG BASE/ML",
"product_no": "002",
"approval_date": "Dec 19, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HALOPERIDOL DECANOATE",
"shortage_reason": "Haloperidol Decanoate Injection",
"shortage_status": "current",
"proprietary_name": "Haloperidol Decanoate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA074893",
"marketing_category": "ANDA",
"nonproprietary_name": "HALOPERIDOL DECANOATE",
"start_marketing_date": "20000712",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N05AD01.
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