Calcium Acetate Capsule
NDC Package 69097-862-83

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

Package Information

Calcium Acetate capsules is calcium acetate is used to prevent high blood phosphate levels in patients who are on dialysis due to severe kidney disease. This formulation utilizes a capsule delivery system. Marketed by Cipla Usa Inc.,, this product is identified by NDC 69097-862 and is authorized under FDA application ANDA203135.

Identification & Billing

NDC Package Code
69097-862-83
Package Description
200 CAPSULE in 1 BOTTLE
Product Code
69097-862
11-Digit Billing Format
69097086283
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
200 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcium Acetate
Non-Proprietary Name
Calcium Acetate
Substance Name
Calcium Acetate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CALCIUM ACETATE 667 mg/1
Pharmacologic Class
Usage Information
Calcium acetate is used to prevent high blood phosphate levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Calcium acetate is a natural mineral that works by holding onto phosphate from the diet so that it can pass out of your body.

Regulatory & Marketing

Labeler Name
Cipla Usa Inc.,
Product Type
Human Prescription Drug
FDA Application #
ANDA203135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69097-862). Click a package code to view its specific billing and regulatory data.

69097-862-03
60 CAPSULE 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 69097-862-83 identifies a specific commercial package of 200 capsule in 1 bottle of Calcium Acetate, a human prescription drug labeled by Cipla Usa Inc.,. This capsule is formulated for oral use and contains calcium acetate 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 Cipla Usa Inc., on July 26, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Calcium acetate is used to prevent high blood phosphate levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Calcium acetate is a natural mineral that works by holding onto phosphate from the diet so that it can pass out of your body.

How is this Cipla Usa Inc., product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097086283. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 200 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)
69097-862-83
11-Digit CMS (5-4-2)
69097-0862-83

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