Metolazone Tablet
NDC Package 46708-533-31

11-digit billing NDC: 46708053331
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Metolazone tablets are indicated for the treatment of salt and water retention including:edema accompanying congestive heart failure;edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. This formulation utilizes a tablet delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-533 and is authorized under FDA application ANDA213251.

Identification & Billing

NDC Package Code
46708-533-31
Package Description
100 TABLET in 1 BOTTLE
Product Code
46708-533
11-Digit Billing Format
46708053331
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metolazone
Non-Proprietary Name
Metolazone
Substance Name
Metolazone
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)
METOLAZONE 5 mg/1
Pharmacologic Class
Usage Information
Metolazone tablets are indicated for the treatment of salt and water retention including:edema accompanying congestive heart failure;edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for ZAROXOLYN and other formulations of metolazone in the treatment of hypertension. Usage in PregnancyThe routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213251
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-02-2020
Listing Expiration
12-31-2027
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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46708-533). Click a package code to view its specific billing and regulatory data.

46708-533-91
1000 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46708-533-31 identifies a specific commercial package of 100 tablet in 1 bottle of Metolazone, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet is formulated for oral use and contains metolazone 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 Alembic Pharmaceuticals Limited on December 02, 2020. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708053331. 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 (5-3-2)
46708-533-31
11-Digit CMS (5-4-2)
46708-0533-31

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