NDC 43598-741

Ramelteon

Ramelteon

Ramelteon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Dr.reddys Laboratories Inc. The primary component is Ramelteon.

Product ID43598-741_614f387c-5d4b-f44f-3f46-0086a121b262
NDC43598-741
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA091693
Labeler NameDr.Reddys Laboratories 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 43598-741-01

100 TABLET in 1 BOTTLE (43598-741-01)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-741-01 [43598074101]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA091693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-22

NDC 43598-741-10 [43598074110]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA091693
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-22

NDC 43598-741-30 [43598074130]

Ramelteon TABLET
Marketing CategoryANDA
Application NumberANDA091693
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-22

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

OpenFDA Data

SPL SET ID:b71cd925-1bae-5a6a-072b-941ad6d3ce65
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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