"64850-300-30" National Drug Code (NDC)

Naltrexone Hydrochloride 30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30)
(Elite Laboratories, Inc.)

NDC Code64850-300-30
Package Description30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30)
Product NDC64850-300
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNaltrexone Hydrochloride
Non-Proprietary NameNaltrexone Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20250815
Marketing Category NameANDA
Application NumberANDA075274
ManufacturerElite Laboratories, Inc.
Substance NameNALTREXONE HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA]

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