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United States · US · US:65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
ARISTADA INITIO
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlkermes, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165757500031 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE
- ndc1165757500041 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
B786J7A343
ARIPIPRAZOLE LAUROXIL
RxCUI 1673265
Orange Book
N209830
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B786J7A343",
"rxcui": "1673265",
"inchikey": "DDINXHAORAAYAD-UHFFFAOYSA-N",
"display_name": "ARIPIPRAZOLE LAUROXIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403": {
"match": "brand_token",
"title": "ARISTADA INITIO (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]",
"spl_version": "16",
"published_date": "2025-02-10"
}
},
"productid": "65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d",
"productndc": "65757-500",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209830",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "675MG/2.4ML (281.25MG/ML)",
"product_no": "001",
"approval_date": "Jun 29, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARIPIPRAZOLE LAUROXIL",
"proprietary_name": "ARISTADA INITIO",
"active_ingred_unit": "mg/2.4mL",
"application_number": "NDA209830",
"marketing_category": "NDA",
"nonproprietary_name": "aripiprazole lauroxil",
"start_marketing_date": "20180629",
"active_numerator_strength": "675"
}Access this data programmatically
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