"80425-0548-2" National Drug Code (NDC)

Tramadol Hydrochloride 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)
(Advanced Rx of Tennessee, LLC)

NDC Code80425-0548-2
Package Description30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)
Product NDC80425-0548
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20250827
Marketing Category NameANDA
Application NumberANDA211825
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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