"0406-8094-01" National Drug Code (NDC)

Oxymorphone Hydrochloride 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8094-01)
(SpecGx LLC)

NDC Code0406-8094-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8094-01)
Product NDC0406-8094
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxymorphone Hydrochloride
Proprietary Name SuffixExtended-release
Non-Proprietary NameOxymorphone Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20140627
Marketing Category NameANDA
Application NumberANDA202946
ManufacturerSpecGx LLC
Substance NameOXYMORPHONE HYDROCHLORIDE
Strength40
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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