NDC 71335-1392 Irbesartan And Hydrochlorothiazide

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71335-1392
Proprietary Name:
Irbesartan And Hydrochlorothiazide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bryant Ranch Prepack
Labeler Code:
71335
Start Marketing Date: [9]
09-30-2019
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - PEACH)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
2875
Score:
1

Product Packages

NDC Code 71335-1392-1

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 71335-1392-2

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Code 71335-1392-3

Package Description: 28 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 71335-1392?

The NDC code 71335-1392 is assigned by the FDA to the product Irbesartan And Hydrochlorothiazide which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 71335-1392-1 30 tablet, film coated in 1 bottle , 71335-1392-2 90 tablet, film coated in 1 bottle , 71335-1392-3 28 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Irbesartan And Hydrochlorothiazide?

Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension.Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy.Irbesartan and hydrochlorothiazide may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.The choice of irbesartan and hydrochlorothiazide as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on irbesartan and hydrochlorothiazide rises to about 40% (systolic) or 70% (diastolic).

Which are Irbesartan And Hydrochlorothiazide UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Irbesartan And Hydrochlorothiazide Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Irbesartan And Hydrochlorothiazide?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 310792 - irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 310792 - hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral Tablet
  • RxCUI: 310792 - HCTZ 12.5 MG / irbesartan 150 MG Oral Tablet

* Please review the disclaimer below.

Patient Education

Hydrochlorothiazide


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.
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Irbesartan


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.
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Blood Pressure Medicines


What is high blood pressure?

High blood pressure, also called hypertension, is when blood puts too much pressure against the walls of your arteries. About 1 in 3 adults have high blood pressure, usually with no symptoms. But it can cause serious problems such as stroke, heart failure, heart attack, and kidney disease.

What lifestyle changes can help lower high blood pressure?

Healthy lifestyle changes can help reduce high blood pressure:

What if lifestyle changes alone cannot lower blood pressure?

Sometimes lifestyle changes alone cannot control or lower your high blood pressure. In that case, your health care provider may prescribe blood pressure medicines.

How do blood pressure medicines work?

Blood pressure medicines work in different ways to lower blood pressure:

  • Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) keep your blood vessels from narrowing as much
  • Calcium channel blockers prevent calcium from entering the muscle cells of your heart and blood vessels. This allows the blood vessels to relax.
  • Diuretics remove extra water and sodium (salt) from your body. This lowers the amount of fluid in your blood. Diuretics are often used with other high blood pressure medicines, sometimes in one combined pill.
  • Beta blockers help your heart beat slower and with less force. This means that your heart pumps less blood through your blood vessels. Beta blockers are typically used only as a backup option or if you also have certain other conditions.

Often, two or more medicines work better than one. While taking the medicines, it is still important to keep up with your healthy lifestyle changes.

NIH: National Heart, Lung, and Blood Institute


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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".