"69189-8088-1" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 1 TABLET, FILM COATED in 1 DOSE PACK (69189-8088-1)
(Avera McKennan Hospital)

NDC Code69189-8088-1
Package Description1 TABLET, FILM COATED in 1 DOSE PACK (69189-8088-1)
Product NDC69189-8088
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride And Acetaminophen
Non-Proprietary NameTramadol Hydrochloride And Acetaminophen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20160210
Marketing Category NameANDA
Application NumberANDA077858
ManufacturerAvera McKennan Hospital
Substance NameTRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Strength37.5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV

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