"0378-1061-05" National Drug Code (NDC)

Guanfacine Hydrochloride 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1061-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1061-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1061-05)
Product NDC0378-1061
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGuanfacine Hydrochloride
Non-Proprietary NameGuanfacine
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150602
Marketing Category NameANDA
Application NumberANDA202578
ManufacturerMylan Pharmaceuticals Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Strength1
Strength Unitmg/1
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]

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