NDC 62856-405

DAYVIGO

Lemborexant

DAYVIGO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eisai Inc.. The primary component is Lemborexant.

• Product ID: 62856-405_08ce5d4f-11e3-42c9-9e5a-801a3afca000
• NDC: 62856-405
• Product Type: Human Prescription Drug
• Proprietary Name: DAYVIGO
• Generic Name: Lemborexant
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA212028
• Labeler Name: Eisai Inc.
• Substance Name: LEMBOREXANT
• Active Ingredient Strength: 5 mg/1
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 62856-405-10

1 BLISTER PACK in 1 CARTON (62856-405-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2020-04-07
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 62856-405-30 [62856040530]

DAYVIGO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA212028
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-07

NDC 62856-405-90 [62856040590]

DAYVIGO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA212028
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-07

NDC 62856-405-10 [62856040510]

DAYVIGO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA212028
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-07

Drug Details

Active Ingredients

Ingredient	Strength
LEMBOREXANT	5 mg/1

OpenFDA Data

• SPL SET ID: 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd
• Manufacturer:
  • Eisai Inc.
• UNII:
  • 0K5743G68X
• RxNorm Concept Unique ID - RxCUI:
  • 2272414
  • 2272408
  • 2288425
  • 2288427
• UPC Code:
  • 0362856410908
  • 0362856405904
  • 0362856405300
  • 0362856410304

NDC Crossover Matching brand name "DAYVIGO" or generic name "Lemborexant"

NDC	Brand Name	Generic Name
62856-405	DAYVIGO	lemborexant
62856-410	DAYVIGO	lemborexant
62856-455	DAYVIGO	lemborexant