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United States · US · US:59651-514_476b92f3-cf7b-4c09-ac67-6ed35e6811d5
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651514033 BLISTER PACK in 1 CARTON (59651-514-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc11596515143030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-514-30)
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A216208
ABAB
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": "59651-514_476b92f3-cf7b-4c09-ac67-6ed35e6811d5",
"productndc": "59651-514",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "216208",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 18, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Feb 18, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Aripiprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216208",
"marketing_category": "ANDA",
"nonproprietary_name": "Aripiprazole",
"start_marketing_date": "20260218",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AX12.
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