"0378-6321-05" National Drug Code (NDC)

Valsartan And Hydrochlorothiazide 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6321-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6321-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6321-05)
Product NDC0378-6321
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameValsartan And Hydrochlorothiazide
Non-Proprietary NameValsartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120921
Marketing Category NameANDA
Application NumberANDA078020
ManufacturerMylan Pharmaceuticals Inc.
Substance NameVALSARTAN; HYDROCHLOROTHIAZIDE
Strength80; 12.5
Strength Unitmg/1; mg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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