NDC 0591-2191

Ramelteon

Ramelteon

Ramelteon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Ramelteon.

Product ID0591-2191_283e5165-3cfa-4b2e-a750-663ee99667f4
NDC0591-2191
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA091610
Labeler NameActavis Pharma, Inc.
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 0591-2191-01

100 TABLET in 1 BOTTLE (0591-2191-01)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2191-01 [00591219101]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA091610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-22

NDC 0591-2191-30 [00591219130]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA091610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-22

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

OpenFDA Data

SPL SET ID:a89dae05-6c39-4072-b8ee-c4c35b46f7d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577348

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    21695-183Rozeremramelteon
    63629-3389Rozeremramelteon
    64764-805Rozeremramelteon
    68151-4881Rozeremramelteon
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