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United States · US · US:76483-101_d7622fbb-a43c-46db-bde4-d05ed7bff185
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSQUARE PHARMACEUTICALS LIMITED
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11764831010030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-101-00)
- ndc11764831010160 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-101-01)
- ndc11764831010290 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-101-02)
- ndc117648310103120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-101-03)
- ndc11764831010430 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-101-04)
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A090165
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": "76483-101_d7622fbb-a43c-46db-bde4-d05ed7bff185",
"productndc": "76483-101",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "090165",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 28, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Aug 28, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "003",
"approval_date": "Aug 28, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG",
"product_no": "004",
"approval_date": "Aug 28, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Aripiprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090165",
"marketing_category": "ANDA",
"nonproprietary_name": "Aripiprazole",
"start_marketing_date": "20220720",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05AX12.
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