"42658-142-07" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 500 TABLET, FILM COATED in 1 BOTTLE (42658-142-07)
(Hisun Pharmaceuticals USA Inc.)

NDC Code42658-142-07
Package Description500 TABLET, FILM COATED in 1 BOTTLE (42658-142-07)
Product NDC42658-142
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20170101
Marketing Category NameANDA
Application NumberANDA207896
ManufacturerHisun Pharmaceuticals USA Inc.
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 [CS]

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