"53002-4320-3" National Drug Code (NDC)

Tramadol Hydrochloride 30 TABLET, COATED in 1 BOTTLE (53002-4320-3)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-4320-3
Package Description30 TABLET, COATED in 1 BOTTLE (53002-4320-3)
Product NDC53002-4320
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20101115
Marketing Category NameANDA
Application NumberANDA076003
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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