"0378-3001-05" National Drug Code (NDC)

Candesartan Cilexetil And Hydrochlorothiazide 500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3001-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05)
Product NDC0378-3001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCandesartan Cilexetil And Hydrochlorothiazide
Non-Proprietary NameCandesartan Cilexetil And Hydrochlorothiazide
Dosage FormTABLET
UsageORAL
Start Marketing Date20121204
Marketing Category NameANDA
Application NumberANDA090704
ManufacturerMylan Pharmaceuticals Inc.
Substance NameCANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Strength16; 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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