"53401-008-31" National Drug Code (NDC)

Naltrexone Hydrochloride 600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code53401-008-31
Package Description600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)
Product NDC53401-008
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNaltrexone Hydrochloride
Non-Proprietary NameNaltrexone Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20150326
End Marketing Date20280630
Marketing Category NameANDA
Application NumberANDA075274
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NameNALTREXONE HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA]

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