"80425-0588-3" National Drug Code (NDC)

Tramadol Hydrochloride 40 TABLET in 1 BOTTLE (80425-0588-3)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0588-3
Package Description40 TABLET in 1 BOTTLE (80425-0588-3)
Product NDC80425-0588
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20260626
Marketing Category NameANDA
Application NumberANDA075968
ManufacturerAdvanced Rx of Tennessee, LLC
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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