NDC 63629-8264

Ramelteon

Ramelteon

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

Product ID63629-8264_e3642a07-b656-4b4b-9c56-d713c8464d8d
NDC63629-8264
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-22
Marketing CategoryANDA / ANDA
Application NumberANDA091610
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 63629-8264-1

30 TABLET in 1 BOTTLE (63629-8264-1)
Marketing Start Date2019-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8264-1 [63629826401]

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

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

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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