"53746-617-10" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 1000 TABLET in 1 BOTTLE (53746-617-10)
(Amneal Pharmaceuticals of New York LLC)

NDC Code53746-617-10
Package Description1000 TABLET in 1 BOTTLE (53746-617-10)
Product NDC53746-617
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride And Acetaminophen
Non-Proprietary NameTramadol Hydrochloride And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20091217
Marketing Category NameANDA
Application NumberANDA090485
ManufacturerAmneal Pharmaceuticals of New York LLC
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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