Tinidazole Tablet, Film Coated
NDC Package 44523-450-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tinidazole tablets is tinidazole is an antibiotic that is used to treat certain types of vaginal infections (bacterial vaginosis, trichomoniasis). This formulation utilizes a tablet, film coated delivery system. Marketed by Biocomp Pharma, Inc., this product is identified by NDC 44523-450 and is authorized under FDA application NDA021618.

Identification & Billing

NDC Package Code
44523-450-12
Package Description
12 TABLET, FILM COATED in 1 BOTTLE
Product Code
44523-450
11-Digit Billing Format
44523045012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA
RxNorm Crosswalk
RxCUI: 199519 - tinidazole 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tinidazole
Non-Proprietary Name
Tinidazole
Substance Name
Tinidazole
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TINIDAZOLE 500 mg/1
Pharmacologic Class
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
Biocomp Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021618
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-20-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (44523-450). Click a package code to view its specific billing and regulatory data.

44523-450-20
20 TABLET, FILM COATED in 1 BOTTLE

* 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 44523-450-12 identifies a specific commercial package of 12 tablet, film coated in 1 bottle of Tinidazole, a human prescription drug labeled by Biocomp Pharma, Inc.. This tablet, film coated is formulated for oral use and contains tinidazole 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 Biocomp Pharma, Inc. on March 20, 2025. The current certification is valid through December 31, 2026.

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 Biocomp Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44523045012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 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 (5-3-2)
44523-450-12
11-Digit CMS (5-4-2)
44523-0450-12

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