NDC 63629-3389

Rozerem

Ramelteon

Rozerem is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ramelteon.

Product ID63629-3389_99c210cf-70b1-4884-a022-ce97addcb810
NDC63629-3389
Product TypeHuman Prescription Drug
Proprietary NameRozerem
Generic NameRamelteon
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-07-22
Marketing CategoryNDA / NDA
Application NumberNDA021782
Labeler NameBryant Ranch Prepack
Substance NameRAMELTEON
Active Ingredient Strength8 mg/1
Pharm ClassesMelatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63629-3389-2

60 TABLET, FILM COATED in 1 BOTTLE (63629-3389-2)
Marketing Start Date2005-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3389-3 [63629338903]

Rozerem TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-27
Marketing End Date2015-10-30

NDC 63629-3389-2 [63629338902]

Rozerem TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-27
Marketing End Date2015-10-30

NDC 63629-3389-1 [63629338901]

Rozerem TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-27
Marketing End Date2015-10-30

NDC 63629-3389-4 [63629338904]

Rozerem TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-27
Marketing End Date2015-10-30

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

OpenFDA Data

SPL SET ID:3fb00527-db09-4c9b-8388-71a891455d65
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 603162
  • 577348

    • Pharmacological Class

    • Melatonin Receptor Agonist [EPC]
    • Melatonin Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Rozerem" or generic name "Ramelteon"

    NDCBrand NameGeneric Name
    21695-183Rozeremramelteon
    63629-3389Rozeremramelteon
    64764-805Rozeremramelteon
    68151-4881Rozeremramelteon
    0591-2191RamelteonRamelteon
    0832-1250RamelteonRamelteon
    42291-776RamelteonRamelteon
    43598-741RamelteonRamelteon
    50268-708RamelteonRamelteon
    50436-3980RamelteonRamelteon
    51407-375RamelteonRamelteon
    52817-235RamelteonRamelteon
    55700-874RamelteonRamelteon
    63629-8264RamelteonRamelteon
    63629-8531RamelteonRamelteon
    70010-028RamelteonRamelteon
    70710-1344RamelteonRamelteon
    70771-1495RamelteonRamelteon
    71205-918RamelteonRamelteon
    71335-1853RamelteonRamelteon
    71335-2186RamelteonRamelteon
    72189-153RAMELTEONRAMELTEON
    72189-369RamelteonRamelteon
    72319-005RamelteonRamelteon
    80425-0203RamelteonRamelteon

    Trademark Results [Rozerem]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROZEREM
    ROZEREM
    78683838 not registered Dead/Abandoned
    Takeda Pharmaceutical Company Limited
    2005-08-02
    ROZEREM
    ROZEREM
    78683793 3449434 Dead/Cancelled
    Takeda Pharmaceutical Company Limited
    2005-08-02
    ROZEREM
    ROZEREM
    78683604 not registered Dead/Abandoned
    Takeda Pharmaceutical Company Limited
    2005-08-02
    ROZEREM
    ROZEREM
    78592113 3449411 Live/Registered
    Takeda Pharmaceutical Company Limited
    2005-03-22
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