"0378-4153-93" National Drug Code (NDC)

Tramadol Hydrochloride 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4153-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4153-93
Package Description30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4153-93)
Product NDC0378-4153
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTramadol Hydrochloride
Non-Proprietary NameTramadol Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20160316
End Marketing Date20220430
Marketing Category NameANDA
Application NumberANDA205257
ManufacturerMylan Pharmaceuticals Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Strength200
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCIV

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