NDC 72319-005

Ramelteon

Ramelteon

Ramelteon is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by I3 Pharmaceuticals, Llc. The primary component is Ramelteon.

Product ID72319-005_8a1d1877-4758-4d82-b1a7-810d2a558a44
NDC72319-005
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA212650
Labeler Namei3 Pharmaceuticals, LLC
Substance NameRAMELTEON
Active Ingredient Strength8 mg/1
Pharm ClassesMelatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72319-005-01

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72319-005-01)
Marketing Start Date2020-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72319-005-04 [72319000504]

Ramelteon TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 72319-005-01 [72319000501]

Ramelteon TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

NDC 72319-005-05 [72319000505]

Ramelteon TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

OpenFDA Data

SPL SET ID:32c52e03-4c2e-4774-9397-f1f0ee99b320
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577348
  • UPC Code
  • 0372319005053
  • 0372319005015
  • 0372319005046
  • Pharmacological Class

    • 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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