NDC 21695-183

Rozerem

Ramelteon

Rozerem is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Ramelteon.

Product ID21695-183_3740dcc6-9ee8-4187-9112-632050043240
NDC21695-183
Product TypeHuman Prescription Drug
Proprietary NameRozerem
Generic NameRamelteon
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-07-22
Marketing CategoryNDA / NDA
Application NumberNDA021782
Labeler NameRebel Distributors Corp
Substance NameRAMELTEON
Active Ingredient Strength8 mg/1
Pharm ClassesMelatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-183-30

30 TABLET, FILM COATED in 1 BOTTLE (21695-183-30)
Marketing Start Date2005-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-183-30 [21695018330]

Rozerem TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-07-22
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
RAMELTEON8 mg/1

Pharmacological Class

  • Melatonin Receptor Agonist [EPC]
  • Melatonin Receptor Agonists [MoA]

NDC Crossover Matching brand name "Rozerem" or generic name "Ramelteon"

NDCBrand NameGeneric Name
21695-183Rozeremramelteon
63629-3389Rozeremramelteon
64764-805Rozeremramelteon
68151-4881Rozeremramelteon
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

Trademark Results [Rozerem]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROZEREM
ROZEREM
78683838 not registered Dead/Abandoned
Takeda Pharmaceutical Company Limited
2005-08-02
ROZEREM
ROZEREM
78683793 3449434 Dead/Cancelled
Takeda Pharmaceutical Company Limited
2005-08-02
ROZEREM
ROZEREM
78683604 not registered Dead/Abandoned
Takeda Pharmaceutical Company Limited
2005-08-02
ROZEREM
ROZEREM
78592113 3449411 Live/Registered
Takeda Pharmaceutical Company Limited
2005-03-22
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