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United States · US · US:65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88
Aripiprazole
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162893741 BOTTLE in 1 CARTON (65162-893-74) / 150 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A203906
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": "65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88",
"productndc": "65162-893",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "203906",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Aug 14, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "Aripiprazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203906",
"marketing_category": "ANDA",
"nonproprietary_name": "Aripiprazole",
"start_marketing_date": "20150817",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AX12.
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