"16590-609-60" National Drug Code (NDC)

Opana 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-609-60)
(STAT RX USA LLC)

NDC Code16590-609-60
Package Description60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-609-60)
Product NDC16590-609
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOpana
Proprietary Name SuffixEr
Non-Proprietary NameOxymorphone Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20060622
Marketing Category NameNDA
Application NumberNDA021610
ManufacturerSTAT RX USA LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Strength40
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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