"0378-5089-73" National Drug Code (NDC)

Varenicline 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5089-73)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5089-73
Package Description56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5089-73)
Product NDC0378-5089
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameVarenicline
Non-Proprietary NameVarenicline
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20240314
Marketing Category NameANDA
Application NumberANDA202019
ManufacturerMylan Pharmaceuticals Inc.
Substance NameVARENICLINE TARTRATE
Strength.5
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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