Tinidazole
NDC Package 63629-8386-1

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.

Tinidazole is an antibiotic that is used to treat certain types of vaginal infections (bacterial vaginosis, trichomoniasis). Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8386 and is authorized under FDA application ANDA202044.

Identification & Billing

NDC Package Code
63629-8386-1
Package Description
4 TABLET in 1 BOTTLE
Product Code
63629-8386
11-Digit Billing Format
63629838601

Clinical Specifications

Proprietary Name
Tinidazole
Dosage Form
-
Usage Information
Tinidazole is an antibiotic that is used to treat certain types of vaginal infections (bacterial vaginosis, trichomoniasis). It is also used to treat certain types of parasite infections (giardiasis, amebiasis). It works by stopping the growth of certain bacteria and parasites. This antibiotic treats only certain bacterial and parasitic 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 #
ANDA202044
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2012
End Marketing Date
01-09-2023
Listing Expiration
01-09-2023
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 63629-8386-1 identifies a specific commercial package of 4 tablet in 1 bottle of Tinidazole, labeled by Bryant Ranch Prepack. 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 April 30, 2012. The current certification is valid through January 09, 2023.

What are the primary indications for this medication?

Tinidazole is an antibiotic that is used to treat certain types of vaginal infections (bacterial vaginosis, trichomoniasis). It is also used to treat certain types of parasite infections (giardiasis, amebiasis). It works by stopping the growth of certain bacteria and parasites. This antibiotic treats only certain bacterial and parasitic 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: 63629838601. 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)
63629-8386-1
11-Digit CMS (5-4-2)
63629-8386-01

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