"76420-105-01" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01)
(Asclemed USA, Inc.)

NDC Code76420-105-01
Package Description1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01)
Product NDC76420-105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride And Acetaminophen
Non-Proprietary NameTramadol Hydrochloride And Acetaminophen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20121215
Marketing Category NameANDA
Application NumberANDA201952
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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