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  5. NDC Package Code: 68462-842-13 Telmisartan And Hydrochlorothiazide

NDC Package 68462-842-13 Telmisartan And Hydrochlorothiazide

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

Table of Contents

    1. Package Information
    2. 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:
68462-842-13
Package Description:
3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code:
68462-842
Proprietary Name:
Telmisartan And Hydrochlorothiazide
Non-Proprietary Name:
Telmisartan And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Telmisartan
Usage Information:
Telmisartan 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan 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 [see Clinical Studies (14)].Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)].Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.
11-Digit NDC Billing Format:
68462084213
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 283316 - telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 283316 - hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet
  • RxCUI: 283316 - HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet
  • RxCUI: 283317 - telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 283317 - hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glenmark Pharmaceuticals Inc., Usa
    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 25 mg/1
  • TELMISARTAN 80 mg/1
    • Pharmacologic Class(es):
  • Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
  • Increased Diuresis - [PE] (Physiologic Effect)
  • Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
  • Thiazides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA202544
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-04-2019
    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.

    Frequently Asked Questions

    What is NDC 68462-842-13?

    The NDC Packaged Code 68462-842-13 is assigned to a package of 3 blister pack in 1 carton / 10 tablet in 1 blister pack of Telmisartan And Hydrochlorothiazide, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68462-842 included in the NDC Directory?

    Yes, Telmisartan And Hydrochlorothiazide with product code 68462-842 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on March 04, 2019 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 68462-842-13?

    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 3.

    What is the 11-digit format for NDC 68462-842-13?

    The 11-digit format is 68462084213. 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
    5-3-268462-842-135-4-268462-0842-13