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United States · US · US:46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11467082611030 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A202102
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": "46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622",
"productndc": "46708-261",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "202102",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 28, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Apr 28, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Aripiprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202102",
"marketing_category": "ANDA",
"nonproprietary_name": "Aripiprazole",
"start_marketing_date": "20150521",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05AX12.
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