Candesartan Cilexetil And Hydrochlorothiazide Tablet
NDC Package 0378-3003-77

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Candesartan Cilexetil And Hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. This formulation utilizes a tablet delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3003 and is authorized under FDA application ANDA090704.

Identification & Billing

NDC Package Code
0378-3003-77
Package Description
90 TABLET in 1 BOTTLE, PLASTIC
Product Code
0378-3003
11-Digit Billing Format
00378300377
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
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

Clinical Specifications

Proprietary Name
Candesartan Cilexetil And Hydrochlorothiazide
Non-Proprietary Name
Candesartan Cilexetil And Hydrochlorothiazide
Substance Name
Candesartan Cilexetil; Hydrochlorothiazide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090704
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2012
End Marketing Date
08-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-3003-77 identifies a specific commercial package of 90 tablet in 1 bottle, plastic of Candesartan Cilexetil And Hydrochlorothiazide, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet is formulated for oral use and contains candesartan cilexetil; hydrochlorothiazide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on December 04, 2012.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378300377. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0378-3003-77
11-Digit CMS (5-4-2)
00378-3003-77

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.