"70518-3386-0" National Drug Code (NDC)

Tramadol Hydrochloride 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3386-0)
(REMEDYREPACK INC.)

NDC Code70518-3386-0
Package Description60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3386-0)
Product NDC70518-3386
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20220311
Marketing Category NameANDA
Application NumberANDA201384
ManufacturerREMEDYREPACK INC.
Substance NameTRAMADOL HYDROCHLORIDE
Strength200
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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