Isoniazid
NDC Package 63629-3707-1

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 Bryant Ranch Prepack, this product is identified by NDC 63629-3707 and is authorized under FDA application ANDA080936.

Identification & Billing

NDC Package Code
63629-3707-1
Package Description
35 TABLET in 1 BOTTLE
Product Code
63629-3707
11-Digit Billing Format
63629370701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
35 EA

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
Bryant Ranch Prepack
FDA Application #
ANDA080936
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-1972
End Marketing Date
09-01-2009
Listing Expiration
09-01-2009
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 63629-3707-1 identifies a specific commercial package of 35 tablet in 1 bottle of Isoniazid, labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 35 billable units per package. 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 Bryant Ranch Prepack on September 01, 1972. The current certification is valid through September 01, 2009.

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 Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629370701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 35 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 (5-4-1)
63629-3707-1
11-Digit CMS (5-4-2)
63629-3707-01

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