NDC 0781-5949 Valsartan 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:
0781-5949
Proprietary Name:
Valsartan And Hydrochlorothiazide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Sandoz Inc
Labeler Code:
0781
Start Marketing Date: [9]
09-21-2012
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)
RED (C48326 - DARK RED)
Shape:
OVAL (C48345)
Size(s):
10 MM
15 MM
Imprint(s):
CG;HGH
CG;HHH
Score:
1

Product Packages

NDC Code 0781-5949-10

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.25649 per EA

NDC Code 0781-5949-64

Package Description: 30 TABLET, FILM COATED in 1 BLISTER PACK

Price per Unit: $0.23963 per EA

NDC Code 0781-5949-84

Package Description: 7000 TABLET, FILM COATED in 1 BOTTLE

NDC Code 0781-5949-92

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.19080 per EA

Product Details

What is NDC 0781-5949?

The NDC code 0781-5949 is assigned by the FDA to the product Valsartan And Hydrochlorothiazide which is product labeled by Sandoz Inc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 0781-5949-10 1000 tablet, film coated in 1 bottle , 0781-5949-64 30 tablet, film coated in 1 blister pack , 0781-5949-84 7000 tablet, film coated in 1 bottle , 0781-5949-92 90 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 Valsartan And Hydrochlorothiazide?

Valsartan and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs.  There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On TherapyValsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components.  Initial TherapyValsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of Valsartan and Hydrochlorothiazide Tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a 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 should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8 Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8 Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8 Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).

Which are Valsartan And Hydrochlorothiazide UNII Codes?

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

Which are Valsartan 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 Valsartan 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: 200284 - HCTZ 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200284 - hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet
  • RxCUI: 200285 - valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 200285 - hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet
  • RxCUI: 200285 - HCTZ 12.5 MG / valsartan 160 MG Oral Tablet

* 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".