NDC 0832-1250

Ramelteon

Ramelteon

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

Product ID0832-1250_95455216-e7c2-434b-bab6-252af64ca84f
NDC0832-1250
Product TypeHuman Prescription Drug
Proprietary NameRamelteon
Generic NameRamelteon
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA213815
Labeler NameUpsher-Smith Laboratories, 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 0832-1250-11

100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11)
Marketing Start Date2020-10-26
NDC Exclude FlagN
Sample Package?N

Drug Details

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.