"0406-3316-01" National Drug Code (NDC)

Hydromorphone Hydrochloride 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3316-01)
(SpecGx LLC)

NDC Code0406-3316-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3316-01)
Product NDC0406-3316
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydromorphone Hydrochloride
Proprietary Name SuffixExtended-release
Non-Proprietary NameHydromorphone Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20140516
End Marketing Date20210430
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA021217
ManufacturerSpecGx LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Strength16
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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