"0378-5091-85" National Drug Code (NDC)

Varenicline 1 KIT in 1 KIT (0378-5091-85) * 11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46) * 42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5091-85
Package Description1 KIT in 1 KIT (0378-5091-85) * 11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46) * 42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)
Product NDC0378-5091
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameVarenicline
Non-Proprietary NameVarenicline
Dosage FormKIT
Start Marketing Date20240314
Marketing Category NameANDA
Application NumberANDA202019
ManufacturerMylan Pharmaceuticals Inc.

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