"33342-057-15" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 500 TABLET, FILM COATED in 1 BOTTLE (33342-057-15)
(Macleods Pharmaceuticals Limited)

NDC Code33342-057-15
Package Description500 TABLET, FILM COATED in 1 BOTTLE (33342-057-15)
Product NDC33342-057
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120927
Marketing Category NameANDA
Application NumberANDA202414
ManufacturerMacleods Pharmaceuticals Limited
Substance NameHYDROCHLOROTHIAZIDE; IRBESARTAN
Strength12.5; 150
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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