"72865-168-01" National Drug Code (NDC)

Hydromorphone Hydrochloride 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-168-01)
(XLCare Pharmaceuticals, Inc.)

NDC Code72865-168-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-168-01)
Product NDC72865-168
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydromorphone Hydrochloride
Non-Proprietary NameHydromorphone Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20200924
Marketing Category NameANDA
Application NumberANDA212133
ManufacturerXLCare Pharmaceuticals, Inc.
Substance NameHYDROMORPHONE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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