0006-0005 : Belsomra 5 mg Oral Tablet, Film Coated


NDC0006-0005
Labeler: Merck Sharp & Dohme Corp.
Product Type: Human Prescription Drug
Drug Name:  Belsomra
Dosage Form: Oral Tablet, Film Coated
Application #: NDA204569
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
Shapes:  Round
Colors:  Yellow
Size (mm): 5
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:

  • 0006-0005-13: 1 BLISTER PACK IN 1 CASE (0006‑0005‑13) > 3 TABLET, FILM COATED IN 1 BLISTER PACK
  • 0006-0005-30: 3 CASE IN 1 CARTON (0006‑0005‑30) > 1 BLISTER PACK IN 1 CASE (0006‑0005‑10) > 10 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Suvorexant

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Copovidone K25-31
  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Titanium Dioxide
  • Triacetin
  • Hypromelloses
  • Ferrosoferric Oxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Orexin Receptor Antagonist [EPC]
  • Orexin Receptor Antagonists [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0006-0033 Belsomra 10 mg Oral Tablet, Film Coated by Merck Sharp & Dohme Corp.
  • 0006-0325 Belsomra 15 mg Oral Tablet, Film Coated by Merck Sharp & Dohme Corp.
  • 0006-0335 Belsomra 20 mg Oral Tablet, Film Coated by Merck Sharp & Dohme Corp.

NDC QR Code

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