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United States · US · US:72603-445_15449fee-e073-7129-e063-6294a90a3538
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172603445011 BOTTLE in 1 CARTON (72603-445-01) / 150 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A216150
AA
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": "ORAL",
"spl_meta": {
"52cc86ba-2c4f-1aba-e063-6294a90a844e": {
"match": "brand_token",
"title": "ARIPIPRAZOLE TABLET [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "72603-445_15449fee-e073-7129-e063-6294a90a3538",
"productndc": "72603-445",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216150",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Nov 1, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Aripiprazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216150",
"marketing_category": "ANDA",
"nonproprietary_name": "Aripiprazole oral",
"start_marketing_date": "20240501",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AX12.
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