NDC 0006-0005

BELSOMRA

Suvorexant

BELSOMRA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Suvorexant.

• Product ID: 0006-0005_0c7a3452-ecb2-4f66-ad52-94f8eaf8cde8
• NDC: 0006-0005
• Product Type: Human Prescription Drug
• Proprietary Name: BELSOMRA
• Generic Name: Suvorexant
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-29
• Marketing Category: NDA / NDA
• Application Number: NDA204569
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: SUVOREXANT
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-0005-13

1 BLISTER PACK in 1 CASE (0006-0005-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2014-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-0005-30 [00006000530]

BELSOMRA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204569
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-29

NDC 0006-0005-13 [00006000513]

BELSOMRA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204569
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-29

NDC 0006-0005-10 [00006000510]

BELSOMRA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204569
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-29

Drug Details

Active Ingredients

Ingredient	Strength
SUVOREXANT	5 mg/1

OpenFDA Data

• SPL SET ID: e5b72731-1acb-45b7-9c13-290ad12d3951
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 081L192FO9
• RxNorm Concept Unique ID - RxCUI:
  • 1547104
  • 1547116
  • 1547114
  • 1547112
  • 1547110
  • 1547575
  • 1547118
  • 1547573

Pharmacological Class

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

NDC Crossover Matching brand name "BELSOMRA" or generic name "Suvorexant"

NDC	Brand Name	Generic Name
0006-0005	BELSOMRA	suvorexant
0006-0033	BELSOMRA	suvorexant
0006-0325	BELSOMRA	suvorexant
0006-0335	BELSOMRA	suvorexant