"0378-4151-01" National Drug Code (NDC)

Tramadol Hydrochloride 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4151-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4151-01)
Product NDC0378-4151
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20020621
End Marketing Date20220831
Marketing Category NameANDA
Application NumberANDA075986
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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