NDC Package 16729-368-15 Olmesartan Medoxomil And Hydrochlorothiazide

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

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:
16729-368-15
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Olmesartan Medoxomil And Hydrochlorothiazide
Non-Proprietary Name:
Olmesartan Medoxomil And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Olmesartan Medoxomil
Usage Information:
Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)] . 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 olmesartan medoxomil 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.Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.
11-Digit NDC Billing Format:
16729036815
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: 403853 - olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 403853 - hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet
  • RxCUI: 403853 - HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet
  • RxCUI: 403854 - olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 403854 - hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Accord Healthcare Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA209281
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-03-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 16729-368-15?

    The NDC Packaged Code 16729-368-15 is assigned to a package of 90 tablet, film coated in 1 bottle of Olmesartan Medoxomil And Hydrochlorothiazide, a human prescription drug labeled by Accord Healthcare Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 16729-368 included in the NDC Directory?

    Yes, Olmesartan Medoxomil And Hydrochlorothiazide with product code 16729-368 is active and included in the NDC Directory. The product was first marketed by Accord Healthcare Inc. on September 03, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16729-368-15?

    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 16729-368-15?

    The 11-digit format is 16729036815. 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
    5-3-216729-368-155-4-216729-0368-15