"70518-3934-0" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 20 TABLET in 1 BOTTLE, PLASTIC (70518-3934-0)
(REMEDYREPACK INC.)

NDC Code70518-3934-0
Package Description20 TABLET in 1 BOTTLE, PLASTIC (70518-3934-0)
Product NDC70518-3934
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride And Acetaminophen
Non-Proprietary NameTramadol Hydrochloride And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20231205
Marketing Category NameANDA
Application NumberANDA090485
ManufacturerREMEDYREPACK INC.
Substance NameACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Strength325; 37.5
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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