United States · FDA National Drug Code directory
LYBALVI
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65757-654_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
- Product NDC
- 65757-654
- Form
- TABLET, FILM COATED
- Composition / generic term
- olanzapine and samidorphan L-malate
- Labeler
- Alkermes, Inc.
- Marketing category
- NDA
- Marketing start / end (source format)
- 20210920
- Source listing expiry
- 20271231
Source-listed ingredients
- OLANZAPINE — 20 mg/1
- SAMIDORPHAN L-MALATE — 10 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 1 BOTTLE in 1 CARTON (65757-654-41) / 7 TABLET, FILM COATED in 1 BOTTLE · 65757-654-41
- 1 BOTTLE in 1 CARTON (65757-654-42) / 30 TABLET, FILM COATED in 1 BOTTLE · 65757-654-42
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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