"0378-0501-01" National Drug Code (NDC)

Bisoprolol Fumarate And Hydrochlorothiazide 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0501-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01)
Product NDC0378-0501
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBisoprolol Fumarate And Hydrochlorothiazide
Non-Proprietary NameBisoprolol Fumarate And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20210222
Marketing Category NameANDA
Application NumberANDA075768
ManufacturerMylan Pharmaceuticals Inc.
Substance NameBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Strength2.5; 6.25
Strength Unitmg/1; mg/1
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]

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