DAYVIGO
- Product NDC
- 62856-405
- 11-digit product format
- 628560405
- Labeler code
- 62856
- Product ID
- 62856-405_c82838dc-6934-4541-8a02-bd44ee5bb82a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lemborexant
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Eisai Inc.
- Application
- NDA212028
- Marketing category
- NDA
- Marketing start
- 2020-04-07
- Substance
- LEMBOREXANT
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DAYVIGO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEMBOREXANT | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5743G68X |
| Rxcui | 2272408, 2272414, 2288425, 2288427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62856-405-10 | DAYVIGO | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 39 |
| 62856-405-10 | DAYVIGO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 39 |
| 62856-405-30 | DAYVIGO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 39 |
| 62856-405-90 | DAYVIGO | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 39 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62856-405 | DAYVIGO (LEMBOREXANT) TABLET, FILM COATED [EISAI INC.] | 39 | Current NDC, Legacy NDC, 4 package rows | 20250303_7074cb65-77b3-45d2-8e8d-da8dc0f70bfd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62856-405-10 | 62856040510 | 1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2020-04-07 | 0000-00-00 | Yes | No | Current |
| 62856-405-30 | 62856040530 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) | | 2020-04-07 | 0000-00-00 | No | No | Current |
| 62856-405-90 | 62856040590 | 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) | | 2020-04-07 | 0000-00-00 | No | No | Current |