"57297-414-06" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 30 TABLET, FILM COATED in 1 BOTTLE (57297-414-06)
(LUPIN LIMITED)

NDC Code57297-414-06
Package Description30 TABLET, FILM COATED in 1 BOTTLE (57297-414-06)
Product NDC57297-414
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20130404
Marketing Category NameANDA
Application NumberANDA201524
ManufacturerLUPIN LIMITED
Substance NameHYDROCHLOROTHIAZIDE; IRBESARTAN
Strength12.5; 300
Strength Unitmg/1; mg/1
Pharmacy ClassesIncreased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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