"69315-402-56" National Drug Code (NDC)

Varenicline Tartrate 56 TABLET, FILM COATED in 1 BOTTLE (69315-402-56)
(Leading Pharma, LLC)

NDC Code69315-402-56
Package Description56 TABLET, FILM COATED in 1 BOTTLE (69315-402-56)
Product NDC69315-402
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameVarenicline Tartrate
Non-Proprietary NameVarenicline Tartrate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20231001
Marketing Category NameANDA
Application NumberANDA217151
ManufacturerLeading Pharma, LLC
Substance NameVARENICLINE TARTRATE
Strength.5
Strength Unitmg/561
Pharmacy ClassesCholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]

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