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United States · US · US:17856-0684_6f744c80-5232-41f6-abad-a81976e0b1f9
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11178560684172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0684-3)
- ndc11178560684272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-0684-4)
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": "17856-0684_6f744c80-5232-41f6-abad-a81976e0b1f9",
"productndc": "17856-0684",
"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": "20231101",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AX12.
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