United States· US:65757-651_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
LYBALVI
A medicinal product containing olanzapine; samidorphan l-malate, registered in United States by Alkermes, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- OLANZAPINE; SAMIDORPHAN L-MALATE
- Manufacturer
- Alkermes, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- 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
- ndc1165757-651-41
- ndc1165757-651-42
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/b6002fdc-635b-4e30-b1a0-0aba753b35f2 GET /v1/drugs/b6002fdc-635b-4e30-b1a0-0aba753b35f2?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "5; 10",
"substance": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"productndc": "65757-651",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA213378",
"marketing_category": "NDA"
}See everything about olanzapine; samidorphan l-malate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.