"65862-631-99" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99)
(Aurobindo Pharma Limited)

NDC Code65862-631-99
Package Description1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99)
Product NDC65862-631
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20160331
Marketing Category NameANDA
Application NumberANDA203630
ManufacturerAurobindo Pharma Limited
Substance NameHYDROCHLOROTHIAZIDE; IRBESARTAN
Strength25; 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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