"68382-319-05" National Drug Code (NDC)

Tramadol Hydrochloride 500 TABLET, FILM COATED in 1 BOTTLE (68382-319-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-319-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (68382-319-05)
Product NDC68382-319
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20110131
Marketing Category NameANDA
Application NumberANDA090404
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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