"0378-1063-01" National Drug Code (NDC)

Guanfacine Hydrochloride 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1063-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1063-01
Package Description100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1063-01)
Product NDC0378-1063
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGuanfacine Hydrochloride
Non-Proprietary NameGuanfacine
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150602
End Marketing Date20191130
Marketing Category NameANDA
Application NumberANDA202578
ManufacturerMylan Pharmaceuticals Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Strength3
Strength Unitmg/1
Pharmacy ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]

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