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NDC 29300-0216-13 Irbesartan and Hydrochlorothiazide 12.5; 300 mg/1; mg/1 Details

Irbesartan and Hydrochlorothiazide 12.5; 300 mg/1; mg/1

Irbesartan and Hydrochlorothiazide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Unichem Pharmaceuticals (USA), Inc.. The primary component is HYDROCHLOROTHIAZIDE; IRBESARTAN.

MedlinePlus Drug Summary

Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Related Packages: 29300-0216-13
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrochlorothiazide

Irbesartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat kidney disease caused by diabetes in patients with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure. Irbesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Related Packages: 29300-0216-13
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Irbesartan

Product Information

NDC	29300-0216
Product ID	29300-216_1dd7c47b-cddf-46d9-ace0-ff4b2a59823a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Irbesartan and Hydrochlorothiazide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Irbesartan and Hydrochlorothiazide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	12.5; 300
Active Ingredient Units	mg/1; mg/1
Substance Name	HYDROCHLOROTHIAZIDE; IRBESARTAN
Labeler Name	Unichem Pharmaceuticals (USA), Inc.
Pharmaceutical Class	Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207018
Listing Certified Through	2024-12-31

Package

NDC 29300-0216-13 (29300021613)

Pricing Information	N/A
NDC Package Code	29300-216-13
Billing NDC	29300021613
Package	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13)
Marketing Start Date	2018-03-31
NDC Exclude Flag	N