"13107-109-05" National Drug Code (NDC)

Hydromorphone Hydrochloride 500 TABLET in 1 BOTTLE (13107-109-05)
(Aurolife Pharma, LLC)

NDC Code13107-109-05
Package Description500 TABLET in 1 BOTTLE (13107-109-05)
Product NDC13107-109
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydromorphone Hydrochloride
Non-Proprietary NameHydromorphone Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20160517
Marketing Category NameANDA
Application NumberANDA205814
ManufacturerAurolife Pharma, LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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