Calcium Carbonate Powder
NDC Package 0395-0431-01

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

Package Information

Calcium Carbonate powders is a medication used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. This formulation utilizes a powder delivery system. Marketed by Humco Holding Group, Inc., this product is identified by NDC 0395-0431 and is authorized under FDA application M001.

Identification & Billing

NDC Package Code
0395-0431-01
Package Description
454 g in 1 BOTTLE, PLASTIC
Product Code
0395-0431
11-Digit Billing Format
00395043101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
454 GM

Clinical Specifications

Proprietary Name
Calcium Carbonate
Non-Proprietary Name
Calcium Carbonate
Substance Name
Calcium Carbonate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CALCIUM CARBONATE 1 g/g
Pharmacologic Class
Usage Information
This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Humco Holding Group, Inc.
Product Type
Human Otc Drug
FDA Application #
M001
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2008
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 0395-0431-01 identifies a specific commercial package of 454 g in 1 bottle, plastic of Calcium Carbonate, a human over the counter drug labeled by Humco Holding Group, Inc.. This product is billed per "GM" gram and contains an estimated amount of 454 billable units per package. This powder is formulated for oral use and contains calcium carbonate 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 Humco Holding Group, Inc. on January 01, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Humco Holding Group, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00395043101. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 454 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)
0395-0431-01
11-Digit CMS (5-4-2)
00395-0431-01

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