NDC Package 0115-5322-02 Nadolol And Bendroflumethiazide

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0115-5322-02
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Nadolol And Bendroflumethiazide
Usage Information:
Nadolol and bendroflumethiazide tablets 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol and bendroflumethiazide tablets.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 one 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 also have 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 (for example, 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.Nadolol and bendroflumethiazide tablets are not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, it may be more convenient than the separate components.
11-Digit NDC Billing Format:
00115532202
NDC to RxNorm Crosswalk:
  • RxCUI: 198000 - nadolol 40 MG / bendroflumethiazide 5 MG Oral Tablet
  • RxCUI: 198000 - bendroflumethiazide 5 MG / nadolol 40 MG Oral Tablet
  • RxCUI: 198001 - nadolol 80 MG / bendroflumethiazide 5 MG Oral Tablet
  • RxCUI: 198001 - bendroflumethiazide 5 MG / nadolol 80 MG Oral Tablet
  • Labeler Name:
    Impax Generics
    Sample Package:
    No
    Start Marketing Date:
    03-30-2007
    Listing Expiration Date:
    12-31-2019
    Exclude Flag:
    I
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0115-5322-01100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0115-5322-02?

    The NDC Packaged Code 0115-5322-02 is assigned to a package of 500 tablet in 1 bottle of Nadolol And Bendroflumethiazide, labeled by Impax Generics. The product's dosage form is and is administered via form.

    Is NDC 0115-5322 included in the NDC Directory?

    No, Nadolol And Bendroflumethiazide with product code 0115-5322 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Impax Generics on March 30, 2007 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0115-5322-02?

    The 11-digit format is 00115532202. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20115-5322-025-4-200115-5322-02