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 ID0006-0005_0c7a3452-ecb2-4f66-ad52-94f8eaf8cde8
NDC0006-0005
Product TypeHuman Prescription Drug
Proprietary NameBELSOMRA
Generic NameSuvorexant
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-08-29
Marketing CategoryNDA / NDA
Application NumberNDA204569
Labeler NameMerck Sharp & Dohme Corp.
Substance NameSUVOREXANT
Active Ingredient Strength5 mg/1
Pharm ClassesOrexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-0005-13

1 BLISTER PACK in 1 CASE (0006-0005-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2014-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-0005-30 [00006000530]

BELSOMRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204569
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-29

NDC 0006-0005-13 [00006000513]

BELSOMRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204569
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-29

NDC 0006-0005-10 [00006000510]

BELSOMRA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204569
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-29

Drug Details

Active Ingredients

IngredientStrength
SUVOREXANT5 mg/1

OpenFDA Data

SPL SET ID:e5b72731-1acb-45b7-9c13-290ad12d3951
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0006-0005BELSOMRAsuvorexant
    0006-0033BELSOMRAsuvorexant
    0006-0325BELSOMRAsuvorexant
    0006-0335BELSOMRAsuvorexant

    Trademark Results [BELSOMRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BELSOMRA
    BELSOMRA
    85831091 4704290 Live/Registered
    Merck Sharp & Dohme Corp
    2013-01-24
    BELSOMRA
    BELSOMRA
    85604810 4363256 Live/Registered
    MERCK SHARP & DOHME CORP.
    2012-04-22
    BELSOMRA
    BELSOMRA
    79009750 3085658 Dead/Cancelled
    H. Lundbeck A/S
    2005-01-28

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