Chlorthalidone Tablet
NDC Package 71610-021-09

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

Package Information

Chlorthalidone tablets is chlorthalidone is used to treat high blood pressure (hypertension). This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-021 and is authorized under FDA application ANDA089286.

Identification & Billing

NDC Package Code
71610-021-09
Package Description
9000 TABLET in 1 BOTTLE
Product Code
71610-021
11-Digit Billing Format
71610002109
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9000 EA
RxNorm Crosswalk
RxCUI: 197500 - chlorthalidone 50 MG Oral Tablet

Clinical Specifications

Proprietary Name
Chlorthalidone
Non-Proprietary Name
Chlorthalidone
Substance Name
Chlorthalidone
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)
CHLORTHALIDONE 50 mg/1
Pharmacologic Class
Usage Information
Chlorthalidone is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to reduce extra salt and water in the body caused by conditions such as heart failure, liver disease, and kidney disease. Decreasing extra salt and water in the body helps to decrease swelling (edema) and breathing problems caused by fluid in the lungs. Chlorthalidone is a "water pill" (diuretic). It increases the amount of urine you make, especially when you first start the medication. It also helps to relax the blood vessels so that blood can flow more easily.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA089286
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2016
Listing Expiration
12-31-2026
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.

* 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 71610-021-09 identifies a specific commercial package of 9000 tablet in 1 bottle of Chlorthalidone, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 9000 billable units per package. This tablet is formulated for oral use and contains chlorthalidone 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 Aphena Pharma Solutions - Tennessee, Llc on February 12, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Chlorthalidone is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to reduce extra salt and water in the body caused by conditions such as heart failure, liver disease, and kidney disease. Decreasing extra salt and water in the body helps to decrease swelling (edema) and breathing problems caused by fluid in the lungs. Chlorthalidone is a "water pill" (diuretic). It increases the amount of urine you make, especially when you first start the medication. It also helps to relax the blood vessels so that blood can flow more easily.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610002109. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 9000 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 (5-3-2)
71610-021-09
11-Digit CMS (5-4-2)
71610-0021-09

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