"76420-983-03" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 3 TABLET in 1 BOTTLE (76420-983-03)
(Asclemed USA, Inc.)

NDC Code76420-983-03
Package Description3 TABLET in 1 BOTTLE (76420-983-03)
Product NDC76420-983
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
ManufacturerAsclemed USA, 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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