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United States · US · US:15370-403_3dbb4e6d-14f0-4668-877c-2f4d9a94751f
OPIPZA
Orange BookUNIISPLATC N05AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCarwin Pharmaceutical Associates, LLC
CountryUS (United States)
ATC codeN05AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11153704033030 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01)
Annotations
UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
N216655
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": {
"b47ede68-8942-4432-af7e-57afc14b2ba4": {
"match": "brand_token",
"title": "OPIPZA (ARIPIPRAZOLE) FILM, SOLUBLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
"spl_version": "2",
"published_date": "2025-01-31"
}
},
"productid": "15370-403_3dbb4e6d-14f0-4668-877c-2f4d9a94751f",
"productndc": "15370-403",
"dosage_form": "FILM, SOLUBLE",
"orange_book": {
"appl_no": "216655",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Jul 22, 2024"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "002",
"approval_date": "Jul 22, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "003",
"approval_date": "Jul 22, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE",
"proprietary_name": "OPIPZA",
"active_ingred_unit": "mg/1",
"application_number": "NDA216655",
"marketing_category": "NDA",
"nonproprietary_name": "ARIPIPRAZOLE",
"start_marketing_date": "20241101",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AX12.
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