Aminosalicylic Acid Granules Granule, Delayed Release
NDC Package 81842-467-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Aminosalicylic Acid Granules granules is a medication used in combination with other drugs to treat tuberculosis. This formulation utilizes a granule, delayed release delivery system. Marketed by Coating Place, Llc, this product is identified by NDC 81842-467.

Identification & Billing

NDC Package Code
81842-467-01
Package Description
70 GRANULE, DELAYED RELEASE in 1 DRUM
Product Code
81842-467
11-Digit Billing Format
81842046701

Clinical Specifications

Proprietary Name
Aminosalicylic Acid Granules
Non-Proprietary Name
Aminosalicylic Acid Granules
Substance Name
Aminosalicylic Acid
Dosage Form
Granule, Delayed Release - A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
Active Ingredient(s)
AMINOSALICYLIC ACID 100 mg/1
Usage Information
This medication is used in combination with other drugs to treat tuberculosis. The treatment of active tuberculosis infection requires taking several drugs in combination for 6 months or longer. This medication may be used as part of this combined drug treatment. Aminosalicylic acid is known as an antituberculosis antibiotic. It works by stopping or slowing the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Coating Place, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-15-1995
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 81842-467-01 identifies a specific commercial package of 70 granule, delayed release in 1 drum of Aminosalicylic Acid Granules (UNFINISHED drug), drug for further processing labeled by Coating Place, Llc. This granule, delayed release is formulated for use and contains aminosalicylic acid 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 Coating Place, Llc on February 15, 1995. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used in combination with other drugs to treat tuberculosis. The treatment of active tuberculosis infection requires taking several drugs in combination for 6 months or longer. This medication may be used as part of this combined drug treatment. Aminosalicylic acid is known as an antituberculosis antibiotic. It works by stopping or slowing the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Coating Place, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81842046701. 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)
81842-467-01
11-Digit CMS (5-4-2)
81842-0467-01

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