Prescription drug · NDA
Dayvigo (Lemborexant) NDC 62856-405
Lemborexant 5 mg/1 · Tablet, Film coated · Oral · Eisai Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62856-405-10 | 62856040510 | 1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 7, 2020 · Sample package | |
| 62856-405-30 | 62856040530 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30)Marketed from Apr 7, 2020 | |
| 62856-405-90 | 62856040590 | 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90)Marketed from Apr 7, 2020 |
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)
- Dayvigo
- Generic name (nonproprietary)
- lemborexant
- Active ingredients
- Lemborexant — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Eisai Inc.NDC labeler code 62856
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212028
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Cytochrome P450 2B6 Inducers (Mechanism)Orexin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62856-405_c82838dc-6934-4541-8a02-bd44ee5bb82aSPL ID c82838dc-6934-4541-8a02-bd44ee5bb82aSPL set ID 7074cb65-77b3-45d2-8e8d-da8dc0f70bfdRxCUI 2272408, 2272414, 2288425, 2288427UNII 0K5743G68XUPC 0362856410304, 0362856405300, 0362856410908, 0362856405904
- Pharmacologic class
- Orexin Receptor 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
N462856040510followed by a unit qualifier and the quantityPackage 62856-0405-10. 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 .
Indications (excerpt from the label)
DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )] . DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62856-405
- What is NDC 62856-405?
- 62856-405 is the product NDC for Dayvigo (lemborexant), Lemborexant 5 mg/1 tablet, film coated, listed with the FDA by Eisai Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dayvigo (Lemborexant).
- What is the active ingredient?
- Lemborexant.
- Who is the labeler?
- Eisai Inc., NDC labeler code 62856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dayvigo?
- 1 other product NDC are listed under this name. See all Dayvigo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dayvigo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dayvigolemborexant | Lemborexant 10 mg/1 | Tablet, Film coatedOral | Eisai Inc. | 62856-410 | 62856-0410-3062856-0410-90 |
Other NDCs under NDA 212028
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 |
|---|---|---|---|---|
| Dayvigolemborexant | Lemborexant 10 mg/1 | Tablet, Film coatedOral | Eisai Inc. | 62856-410 |