"60219-2348-1" National Drug Code (NDC)

Tramadol Hydrochloride 100 TABLET, COATED in 1 BOTTLE (60219-2348-1)
(Amneal Pharmaceuticals NY LLC)

NDC Code60219-2348-1
Package Description100 TABLET, COATED in 1 BOTTLE (60219-2348-1)
Product NDC60219-2348
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20230213
Marketing Category NameANDA
Application NumberANDA076003
ManufacturerAmneal Pharmaceuticals NY LLC
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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