"65862-922-05" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05)
(Aurobindo Pharma Limited)

NDC Code65862-922-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05)
Product NDC65862-922
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride And Acetaminophen
Non-Proprietary NameTramadol Hydrochloride And Acetaminophen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20170322
Marketing Category NameANDA
Application NumberANDA207152
ManufacturerAurobindo Pharma Limited
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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