"53217-105-02" National Drug Code (NDC)

Tramadol Hydrochloride 120 TABLET, COATED in 1 BOTTLE (53217-105-02)
(Aidarex Pharmaceuticals LLC)

NDC Code53217-105-02
Package Description120 TABLET, COATED in 1 BOTTLE (53217-105-02)
Product NDC53217-105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20101115
Marketing Category NameANDA
Application NumberANDA076003
ManufacturerAidarex Pharmaceuticals LLC
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV

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