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  5. NDC Package Code: 0378-3003-77 Candesartan Cilexetil And Hydrochlorothiazide

NDC Package 0378-3003-77 Candesartan Cilexetil 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:
0378-3003-77
Package Description:
90 TABLET in 1 BOTTLE, PLASTIC
Product Code:
0378-3003
Proprietary Name:
Candesartan Cilexetil And Hydrochlorothiazide
Non-Proprietary Name:
Candesartan Cilexetil And Hydrochlorothiazide
Substance Name:
Candesartan Cilexetil; Hydrochlorothiazide
Usage Information:
Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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 candesartan cilexetil 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 dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
11-Digit NDC Billing Format:
00378300377
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: 578325 - candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 578325 - candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral Tablet
  • RxCUI: 578325 - candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 578330 - candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 578330 - candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan 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):
  • CANDESARTAN CILEXETIL 32 mg/1
  • HYDROCHLOROTHIAZIDE 25 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:
    ANDA090704
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-04-2012
    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 0378-3003-77?

    The NDC Packaged Code 0378-3003-77 is assigned to a package of 90 tablet in 1 bottle, plastic of Candesartan Cilexetil And Hydrochlorothiazide, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0378-3003 included in the NDC Directory?

    Yes, Candesartan Cilexetil And Hydrochlorothiazide with product code 0378-3003 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on December 04, 2012 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 0378-3003-77?

    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 0378-3003-77?

    The 11-digit format is 00378300377. 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
    4-4-20378-3003-775-4-200378-3003-77