NDC 70710-1344

Ramelteon

Ramelteon

Ramelteon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Ramelteon.

Product ID70710-1344_61413940-2f21-450e-93ef-7689f114932d
NDC70710-1344
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-23
Marketing CategoryANDA / ANDA
Application NumberANDA211567
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameRAMELTEON
Active Ingredient Strength8 mg/1
Pharm ClassesMelatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70710-1344-1

100 TABLET in 1 BOTTLE (70710-1344-1)
Marketing Start Date2019-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1344-3 [70710134403]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA211567
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-23

NDC 70710-1344-1 [70710134401]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA211567
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-23

NDC 70710-1344-5 [70710134405]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA211567
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

OpenFDA Data

SPL SET ID:5db0e3ff-fefb-4c54-b9f9-b555e482e147
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577348
  • UPC Code
  • 0370710134433
  • 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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