"53401-032-84" National Drug Code (NDC)

Varenicline 1008 TABLET, FILM COATED in 1 BOTTLE (53401-032-84)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code53401-032-84
Package Description1008 TABLET, FILM COATED in 1 BOTTLE (53401-032-84)
Product NDC53401-032
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameVarenicline
Non-Proprietary NameVarenicline
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230130
Marketing Category NameANDA
Application NumberANDA201962
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NameVARENICLINE TARTRATE
Strength1
Strength Unitmg/1
Pharmacy ClassesCholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]

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