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United States · US · US:65757-651_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
LYBALVI
Orange BookUNIISPLATC N05AH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlkermes, Inc.
CountryUS (United States)
ATC codeN05AH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165757651411 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE
- ndc1165757651421 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
N213378
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N7U69T4SZR",
"rxcui": "61381",
"inchikey": "KVWDHTXUZHCGIO-UHFFFAOYSA-N",
"display_name": "OLANZAPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"32ffddd1-4e2b-45d9-9b36-bb730167ec80": {
"match": "brand_token",
"title": "LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE) TABLET, FILM COATED [ALKERMES, INC.]",
"spl_version": "16",
"published_date": "2026-02-16"
}
},
"productid": "65757-651_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4",
"productndc": "65757-651",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213378",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG;EQ 10MG BASE",
"product_no": "001",
"approval_date": "May 28, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG;EQ 10MG BASE",
"product_no": "002",
"approval_date": "May 28, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG;EQ 10MG BASE",
"product_no": "003",
"approval_date": "May 28, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG;EQ 10MG BASE",
"product_no": "004",
"approval_date": "May 28, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"proprietary_name": "LYBALVI",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA213378",
"marketing_category": "NDA",
"nonproprietary_name": "olanzapine and samidorphan L-malate",
"start_marketing_date": "20210920",
"active_numerator_strength": "5; 10"
}Related drugs
Other records sharing ATC code N05AH.
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