"10135-838-01" National Drug Code (NDC)

Ramelteon 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01)
(Marlex Pharmaceuticals, Inc.)

NDC Code10135-838-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01)
Product NDC10135-838
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRamelteon
Non-Proprietary NameRamelteon
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20260701
Marketing Category NameANDA
Application NumberANDA215435
ManufacturerMarlex Pharmaceuticals, Inc.
Substance NameRAMELTEON
Strength8
Strength Unitmg/1
Pharmacy ClassesMelatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]

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