Moxifloxacin Hydrochloride Tablets, 400 Mg Tablet, Film Coated
NDC Package 72789-080-10

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

Package Information

Moxifloxacin Hydrochloride Tablets, 400 Mg tablets is moxifloxacin hydrochloride is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-080 and is authorized under FDA application ANDA208682.

Identification & Billing

NDC Package Code
72789-080-10
Package Description
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
72789-080
11-Digit Billing Format
72789008010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Moxifloxacin Hydrochloride Tablets, 400 Mg
Non-Proprietary Name
Moxifloxacin Hydrochloride Tablets, 400 Mg
Substance Name
Moxifloxacin Hydrochloride Monohydrate
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)
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 400 mg/1
Pharmacologic Class
Usage Information
Moxifloxacin hydrochloride is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8)].

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-21-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72789-080-10 identifies a specific commercial package of 10 tablet, film coated in 1 bottle, plastic of Moxifloxacin Hydrochloride Tablets, 400 Mg, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This tablet, film coated is formulated for oral use and contains moxifloxacin hydrochloride monohydrate 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 Pd-rx Pharmaceuticals, Inc. on July 21, 2018. The current certification is valid through December 31, 2026.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789008010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
72789-080-10
11-Digit CMS (5-4-2)
72789-0080-10

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