"0378-3033-05" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 500 TABLET in 1 BOTTLE, PLASTIC (0378-3033-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3033-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-3033-05)
Product NDC0378-3033
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET
UsageORAL
Start Marketing Date20120927
Marketing Category NameANDA
Application NumberANDA077969
ManufacturerMylan Pharmaceuticals Inc.
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 [Chemical/Ingredient]

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