"64764-805-10" National Drug Code (NDC)

Rozerem 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
(Takeda Pharmaceuticals America, Inc.)

NDC Code64764-805-10
Package Description100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
Product NDC64764-805
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRozerem
Non-Proprietary NameRamelteon
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20050722
Marketing Category NameNDA
Application NumberNDA021782
ManufacturerTakeda Pharmaceuticals America, Inc.
Substance NameRAMELTEON
Strength8
Strength Unitmg/1
Pharmacy ClassesMelatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]

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