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Irbesartan and Hydrochlorothiazide - 0054-0254-13 - (Irbesartan and Hydrochlorothiazide)

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Drug Information of Irbesartan and Hydrochlorothiazide

Product NDC: 0054-0254
Proprietary Name: Irbesartan and Hydrochlorothiazide
Non Proprietary Name: Irbesartan and Hydrochlorothiazide
Active Ingredient(s): 12.5; 150    mg/1; mg/1 & nbsp;   Irbesartan and Hydrochlorothiazide
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Irbesartan and Hydrochlorothiazide

Product NDC: 0054-0254
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090351
Marketing Category: ANDA
Start Marketing Date: 20121015

Package Information of Irbesartan and Hydrochlorothiazide

Package NDC: 0054-0254-13
Package Description: 30 TABLET in 1 BOTTLE (0054-0254-13)

NDC Information of Irbesartan and Hydrochlorothiazide

NDC Code 0054-0254-13
Proprietary Name Irbesartan and Hydrochlorothiazide
Package Description 30 TABLET in 1 BOTTLE (0054-0254-13)
Product NDC 0054-0254
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Irbesartan and Hydrochlorothiazide
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20121015
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name HYDROCHLOROTHIAZIDE; IRBESARTAN
Strength Number 12.5; 150
Strength Unit mg/1; mg/1
Pharmaceutical Classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]

Complete Information of Irbesartan and Hydrochlorothiazide


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