"0054-0386-63" National Drug Code (NDC)

Hydromorphone Hydrochloride 473 mL in 1 BOTTLE (0054-0386-63)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0386-63
Package Description473 mL in 1 BOTTLE (0054-0386-63)
Product NDC0054-0386
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydromorphone Hydrochloride
Non-Proprietary NameHydromorphone Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20120301
Marketing Category NameANDA
Application NumberANDA074653
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameHYDROMORPHONE HYDROCHLORIDE
Strength1
Strength Unitmg/mL
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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