"0054-8535-16" National Drug Code (NDC)

Loperamide Hydrochloride 10 mL in 1 CUP, UNIT-DOSE (0054-8535-16)
(Roxane Laboratories, Inc)

NDC Code0054-8535-16
Package Description10 mL in 1 CUP, UNIT-DOSE (0054-8535-16)
Product NDC0054-8535
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLoperamide Hydrochloride
Non-Proprietary NameLoperamide Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date19920430
Marketing Category NameANDA
Application NumberANDA073079
ManufacturerRoxane Laboratories, Inc
Substance NameLOPERAMIDE HYDROCHLORIDE
Strength2
Strength Unitmg/10mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]

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