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United States · US · US:27241-207_430dc8c4-7349-42d5-9036-b0bdcc02a839
Brexpiprazole
Orange BookUNIIATC N05AX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeN05AX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11272412073030 TABLET in 1 BOTTLE (27241-207-30)
Annotations
UNII (FDA Substance ID)
2J3YBM1K8C
BREXPIPRAZOLE
RxCUI 1658314
Orange Book
A213718
Raw payload (JSON)
{
"unii": {
"unii": "2J3YBM1K8C",
"rxcui": "1658314",
"inchikey": "ZKIAIYBUSXZPLP-UHFFFAOYSA-N",
"display_name": "BREXPIPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "27241-207_430dc8c4-7349-42d5-9036-b0bdcc02a839",
"productndc": "27241-207",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213718",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.25MG",
"product_no": "001",
"approval_date": "Feb 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.5MG",
"product_no": "002",
"approval_date": "Feb 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG",
"product_no": "003",
"approval_date": "Feb 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG",
"product_no": "004",
"approval_date": "Feb 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "3MG",
"product_no": "005",
"approval_date": "Feb 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "4MG",
"product_no": "006",
"approval_date": "Feb 3, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BREXPIPRAZOLE",
"proprietary_name": "Brexpiprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213718",
"marketing_category": "ANDA",
"nonproprietary_name": "Brexpiprazole",
"start_marketing_date": "20230203",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05AX16.
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