"0574-0295-01" National Drug Code (NDC)

Hydromorphone Hydrochloride 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0295-01)
(Padagis US LLC)

NDC Code0574-0295-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0295-01)
Product NDC0574-0295
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydromorphone Hydrochloride
Non-Proprietary NameHydromorphone Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150522
Marketing Category NameANDA
Application NumberANDA204278
ManufacturerPadagis US LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Strength16
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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