"70518-1386-0" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 90 TABLET in 1 BOTTLE, PLASTIC (70518-1386-0)
(REMEDYREPACK INC.)

NDC Code70518-1386-0
Package Description90 TABLET in 1 BOTTLE, PLASTIC (70518-1386-0)
Product NDC70518-1386
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET
UsageORAL
Start Marketing Date20180827
Marketing Category NameANDA
Application NumberANDA090351
ManufacturerREMEDYREPACK 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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