Prescription drug · NDA
Lybalvi (Olanzapine and samidorphan l-malate) NDC 65757-653
Olanzapine 15 mg/1; Samidorphan l-malate 10 mg/1 · Tablet, Film coated · Oral · Alkermes, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65757-653-41 | 65757065341 | 1 BOTTLE in 1 CARTON (65757-653-41) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2021 · Sample package | |
| 65757-653-42 | 65757065342 | 1 BOTTLE in 1 CARTON (65757-653-42) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 20, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lybalvi
- Generic name (nonproprietary)
- olanzapine and samidorphan l-malate
- Active ingredients
- Olanzapine — 15 mg/1Samidorphan l-malate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alkermes, Inc.NDC labeler code 65757
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213378
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 65757-653_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4SPL ID 44ae69cc-b9a6-4658-90fa-1dbef1e97eb4SPL set ID 32ffddd1-4e2b-45d9-9b36-bb730167ec80RxCUI 2570392, 2570398, 2570399, 2570401, 2570402, 2570404, 2570405, 2570407UNII N7U69T4SZR, 0AJQ5N56E0
- Pharmacologic class
- Atypical Antipsychotic; Opioid Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465757065341followed by a unit qualifier and the quantityPackage 65757-0653-41. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adults ( 1 ) Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment
Excerpt only. Read the full label for complete information.
About NDC 65757-653
- What is NDC 65757-653?
- 65757-653 is the product NDC for Lybalvi, Olanzapine 15 mg/1; Samidorphan l-malate 10 mg/1 tablet, film coated, listed with the FDA by Alkermes, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lybalvi (Olanzapine and samidorphan L-malate).
- What is the active ingredient?
- Olanzapine, Samidorphan l-malate.
- Who is the labeler?
- Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lybalvi?
- 1 other product NDC are listed under this name. See all Lybalvi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lybalvi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lybalviolanzapine and samidorphan l-malate | Olanzapine 10 mg/1; Samidorphan l-malate 10 mg/1 | Tablet, Film coatedOral | Alkermes, Inc. | 65757-652 | 65757-0652-4165757-0652-42 |
Other NDCs under NDA 213378
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lybalviolanzapine and samidorphan l-malate | Olanzapine 10 mg/1; Samidorphan l-malate 10 mg/1 | Tablet, Film coatedOral | Alkermes, Inc. | 65757-652 |