Isoniazid
NDC Package 71610-108-30

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-108 and is authorized under FDA application ANDA089776.

Identification & Billing

NDC Package Code
71610-108-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
71610-108
11-Digit Billing Format
71610010830

Clinical Specifications

Proprietary Name
Isoniazid
Dosage Form
-
Usage Information
Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping 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
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA089776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-10-2013
End Marketing Date
08-31-2018
Listing Expiration
08-31-2018
Exclude Flag
D
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 71610-108-30 identifies a specific commercial package of 30 tablet in 1 bottle of Isoniazid, labeled by Aphena Pharma Solutions - Tennessee, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on October 10, 2013. The current certification is valid through August 31, 2018.

What are the primary indications for this medication?

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping 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 Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610010830. 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)
71610-108-30
11-Digit CMS (5-4-2)
71610-0108-30

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