62856-405 : Dayvigo 5 mg Oral Tablet, Film Coated


NDC: 62856-405
Labeler: Eisai Inc.
Product Type: Human Prescription Drug
Drug Name:  Dayvigo
Dosage Form: Oral Tablet, Film Coated
Application #: NDA212028
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 5;LEM
Shapes:  Round
Colors:  Yellow
Size (mm): 7
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 62856-405-10: 1 BLISTER PACK IN 1 CARTON (62856‑405‑10) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
  • 62856-405-30: 30 TABLET, FILM COATED IN 1 BOTTLE (62856‑405‑30)
  • 62856-405-90: 90 TABLET, FILM COATED IN 1 BOTTLE (62856‑405‑90)

Active Ingredients:

  • Lemborexant

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Water
  • Lactose Monohydrate
  • Low-substituted Hydroxypropyl Cellulose (11% Hydroxypropyl
  • 120000 Mw)
  • Hydroxypropyl Cellulose (45000 Wamw)
  • Magnesium Stearate
  • Hypromellose 2910 (6 Mpa.s)
  • Talc
  • Polyethylene Glycol 8000
  • Titanium Dioxide
  • Ferric Oxide Yellow /

Pharmaceutical Classes:

  • Cytochrome P450 2B6 Inducers [MoA]
  • Orexin Receptor Antagonist [EPC]
  • Orexin Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 62856-410 Dayvigo 10 mg Oral Tablet, Film Coated by Eisai Inc.
  • 62856-455 Dayvigo 5 mg Oral Tablet, Film Coated by Eisai Inc.

NDC QR Code

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NDC 62856-405 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.