"0054-0255-13" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 30 TABLET in 1 BOTTLE (0054-0255-13)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0255-13
Package Description30 TABLET in 1 BOTTLE (0054-0255-13)
Product NDC0054-0255
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET
UsageORAL
Start Marketing Date20121015
Marketing Category NameANDA
Application NumberANDA090351
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameHYDROCHLOROTHIAZIDE; IRBESARTAN
Strength12.5; 300
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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