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United States · US · US:61874-130_db2154b0-f0c7-403c-95fd-794666e79e30
Vraylar
Orange BookUNIISPLATC N05AX15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeN05AX15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1161874130077 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-07)
- ndc1161874130202 BLISTER PACK in 1 CARTON (61874-130-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-11)
- ndc11618741303030 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-130-30)
Annotations
UNII (FDA Substance ID)
F6RJL8B278
CARIPRAZINE
RxCUI 1667655
Orange Book
N204370
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F6RJL8B278",
"rxcui": "1667655",
"inchikey": "KPWSJANDNDDRMB-QAQDUYKDSA-N",
"display_name": "CARIPRAZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4b5f7c65-aa2d-452a-b3db-bc85c06ff12f": {
"match": "brand_token",
"title": "VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED VRAYLAR (CARIPRAZINE) KIT [ALLERGAN, INC.]",
"spl_version": "30",
"published_date": "2025-12-31"
}
},
"productid": "61874-130_db2154b0-f0c7-403c-95fd-794666e79e30",
"productndc": "61874-130",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "204370",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1.5MG BASE",
"product_no": "001",
"approval_date": "Sep 17, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 3MG BASE",
"product_no": "002",
"approval_date": "Sep 17, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 4.5MG BASE",
"product_no": "003",
"approval_date": "Sep 17, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 6MG BASE",
"product_no": "004",
"approval_date": "Sep 17, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.5MG BASE",
"product_no": "005",
"approval_date": "Dec 18, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.75MG BASE",
"product_no": "006",
"approval_date": "Dec 18, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARIPRAZINE",
"proprietary_name": "Vraylar",
"active_ingred_unit": "mg/1",
"application_number": "NDA204370",
"marketing_category": "NDA",
"nonproprietary_name": "cariprazine",
"start_marketing_date": "20150917",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05AX15.
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