"60505-3604-9" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 90 TABLET, FILM COATED in 1 BOTTLE (60505-3604-9)
(Apotex Corp.)

NDC Code60505-3604-9
Package Description90 TABLET, FILM COATED in 1 BOTTLE (60505-3604-9)
Product NDC60505-3604
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20121016
Marketing Category NameANDA
Application NumberANDA201505
ManufacturerApotex Corp.
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Strength300; 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 [Chemical/Ingredient]

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