"70518-1331-0" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1331-0)
(REMEDYREPACK INC.)

NDC Code70518-1331-0
Package Description90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1331-0)
Product NDC70518-1331
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20180730
Marketing Category NameANDA
Application NumberANDA202414
ManufacturerREMEDYREPACK INC.
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Strength150; 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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