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United States · US · US:75929-273_4b1b593e-c89a-821e-e063-6394a90a06cd
Rexulti
Orange BookUNIISPLATC N05AX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharma Packaging Solutions, LLC dba Tjoapack LLC
CountryUS (United States)
ATC codeN05AX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1175929273031 BOTTLE in 1 CARTON (75929-273-03) / 30 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2J3YBM1K8C
BREXPIPRAZOLE
RxCUI 1658314
Orange Book
N205422
ABABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2J3YBM1K8C",
"rxcui": "1658314",
"inchikey": "ZKIAIYBUSXZPLP-UHFFFAOYSA-N",
"display_name": "BREXPIPRAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2d301358-6291-4ec1-bd87-37b4ad9bd850": {
"match": "brand_token",
"title": "REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
"spl_version": "26",
"published_date": "2026-05-28"
}
},
"productid": "75929-273_4b1b593e-c89a-821e-e063-6394a90a06cd",
"productndc": "75929-273",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205422",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "001",
"approval_date": "Jul 10, 2015"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "002",
"approval_date": "Jul 10, 2015"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "1MG",
"product_no": "003",
"approval_date": "Jul 10, 2015"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2MG",
"product_no": "004",
"approval_date": "Jul 10, 2015"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "3MG",
"product_no": "005",
"approval_date": "Jul 10, 2015"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "4MG",
"product_no": "006",
"approval_date": "Jul 10, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BREXPIPRAZOLE",
"proprietary_name": "Rexulti",
"active_ingred_unit": "mg/1",
"application_number": "NDA205422",
"marketing_category": "NDA",
"nonproprietary_name": "brexpiprazole",
"start_marketing_date": "20150710",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N05AX16.
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