Moxidectin Tablet
NDC Package 71705-050-01

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

Package Information

Moxidectin tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older [see Clinical Studies (14)]. This formulation utilizes a tablet delivery system. Marketed by Medicines Development For Global Health, this product is identified by NDC 71705-050 and is authorized under FDA application NDA210867.

Identification & Billing

NDC Package Code
71705-050-01
Package Description
500 TABLET in 1 BOTTLE, PLASTIC
Product Code
71705-050
11-Digit Billing Format
71705005001
RxNorm Crosswalk
RxCUI: 2049015 - moxidectin 2 MG Oral Tablet

Clinical Specifications

Proprietary Name
Moxidectin
Non-Proprietary Name
Moxidectin
Substance Name
Moxidectin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MOXIDECTIN 2 mg/1
Usage Information
Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older [see Clinical Studies (14)]. Limitations of Use: Moxidectin Tablets do not kill adult O. volvulus. Follow-up evaluation is advised. The safety and efficacy of repeat administration of Moxidectin Tablets in patients with O. volvulus has not been studied.

Regulatory & Marketing

Labeler Name
Medicines Development For Global Health
Product Type
Human Prescription Drug
FDA Application #
NDA210867
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-02-2019
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 71705-050-01 identifies a specific commercial package of 500 tablet in 1 bottle, plastic of Moxidectin, a human prescription drug labeled by Medicines Development For Global Health. This tablet is formulated for oral use and contains moxidectin 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 Medicines Development For Global Health on December 02, 2019. The current certification is valid through December 31, 2026.

How is this Medicines Development For Global Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71705005001. 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)
71705-050-01
11-Digit CMS (5-4-2)
71705-0050-01

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