"82582-485-56" National Drug Code (NDC)

Varenicline 56 TABLET, FILM COATED in 1 BOTTLE (82582-485-56)
(AVALANCHE PHARMACEUTICAL LLC)

NDC Code82582-485-56
Package Description56 TABLET, FILM COATED in 1 BOTTLE (82582-485-56)
Product NDC82582-485
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameVarenicline
Non-Proprietary NameVarenicline Tartrate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20240319
Marketing Category NameANDA
Application NumberANDA217283
ManufacturerAVALANCHE PHARMACEUTICAL LLC
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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