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"65862-922-78" National Drug Code (NDC)

Tramadol Hydrochloride And Acetaminophen 10 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10)
(Aurobindo Pharma Limited)

NDC Code65862-922-78
Package Description10 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10)
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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