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  5. NDC Package Code: 43386-710-09 Quinapril Hcl And Hydrochlorothiazide

NDC Package 43386-710-09 Quinapril Hcl And Hydrochlorothiazide

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
43386-710-09
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
43386-710
Proprietary Name:
Quinapril Hcl And Hydrochlorothiazide
Non-Proprietary Name:
Quinapril Hcl And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Quinapril Hydrochloride
Usage Information:
Hypertension: Quinapril Hydrochloride and Hydrochlorothiazide 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 class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Quinapril Hydrochloride and Hydrochlorothiazide 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.This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).In using Quinapril Hydrochloride and Hydrochlorothiazide Tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).Angioedema in Black Patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
11-Digit NDC Billing Format:
43386071009
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 310796 - quinapril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 310796 - hydrochlorothiazide 12.5 MG / quinapril 10 MG Oral Tablet
  • RxCUI: 310796 - HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 10 MG Oral Tablet
  • RxCUI: 310796 - HCTZ 12.5 MG / quinapril 10 MG Oral Tablet
  • RxCUI: 310797 - quinapril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDROCHLOROTHIAZIDE 12.5 mg/1
  • QUINAPRIL HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Angiotensin Converting Enzyme Inhibitor - [EPC] (Established Pharmacologic Class)
  • Angiotensin-converting Enzyme Inhibitors - [MoA] (Mechanism of Action)
  • Increased Diuresis - [PE] (Physiologic Effect)
  • Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
  • Thiazides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA076374
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-15-2011
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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
    43386-710-05500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43386-710-09?

    The NDC Packaged Code 43386-710-09 is assigned to a package of 90 tablet in 1 bottle of Quinapril Hcl And Hydrochlorothiazide, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 43386-710 included in the NDC Directory?

    Yes, Quinapril Hcl And Hydrochlorothiazide with product code 43386-710 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on July 15, 2011 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43386-710-09?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 43386-710-09?

    The 11-digit format is 43386071009. 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 5-3-2 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
    5-3-243386-710-095-4-243386-0710-09