Isoniazid
NDC Package 61748-016-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. Marketed by Versapharm Incorporated, this product is identified by NDC 61748-016 and is authorized under FDA application ANDA080212.

Identification & Billing

NDC Package Code
61748-016-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
61748-016
11-Digit Billing Format
61748001601
RxNorm Crosswalk

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
Versapharm Incorporated
FDA Application #
ANDA080212
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-1997
Listing Expiration
12-31-2018
Exclude Flag
I
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 61748-016-01 identifies a specific commercial package of 100 tablet in 1 bottle of Isoniazid, labeled by Versapharm Incorporated. 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 Versapharm Incorporated on September 01, 1997. The current certification is valid through December 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 Versapharm Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61748001601. 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)
61748-016-01
11-Digit CMS (5-4-2)
61748-0016-01

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