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United States · US · US:59148-102_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c
Abilify Asimtufii
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOtsuka America Pharmaceutical, Inc
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159148102801 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
N217006
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "82VFR53I78",
"rxcui": "89013",
"inchikey": "CEUORZQYGODEFX-UHFFFAOYSA-N",
"display_name": "ARIPIPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6": {
"match": "brand_token",
"title": "ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
"spl_version": "27",
"published_date": "2026-03-30"
}
},
"productid": "59148-102_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c",
"productndc": "59148-102",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "217006",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "720MG/2.4ML (300MG/ML)",
"product_no": "001",
"approval_date": "Apr 27, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "960MG/3.2ML (300MG/ML)",
"product_no": "002",
"approval_date": "Apr 27, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Abilify Asimtufii",
"active_ingred_unit": "mg/2.4mL",
"application_number": "NDA217006",
"marketing_category": "NDA",
"nonproprietary_name": "Aripiprazole",
"start_marketing_date": "20230427",
"active_numerator_strength": "720"
}Related drugs
Other records sharing ATC code N05AX12.
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