Lucemyra Tablet, Film Coated
NDC Package 78670-050-36

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Lucemyra (lofexidine hydrochloride) tablets is lofexidine is used to decrease withdrawal symptoms caused by stopping opioids. This formulation utilizes a tablet, film coated delivery system. Marketed by Uswm, Llc, this product is identified by NDC 78670-050 and is authorized under FDA application NDA209229.

Identification & Billing

NDC Package Code
78670-050-36
Package Description
1 BOTTLE in 1 CARTON / 36 TABLET, FILM COATED in 1 BOTTLE
Product Code
78670-050
11-Digit Billing Format
78670005036
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lucemyra
Non-Proprietary Name
Lofexidine Hydrochloride
Substance Name
Lofexidine Hydrochloride
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)
LOFEXIDINE HYDROCHLORIDE .2 mg/1
Usage Information
Lofexidine is used to decrease withdrawal symptoms caused by stopping opioids. It can be used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Regulatory & Marketing

Labeler Name
Uswm, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209229
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-09-2021
End Marketing Date
08-31-2026
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 (78670-050). Click a package code to view its specific billing and regulatory data.

78670-050-03
1 BOTTLE in 1 CARTON / 36 TABLET, FILM COATED in 1 BOTTLE
78670-050-96
1 BOTTLE in 1 CARTON / 96 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 78670-050-36 identifies a specific commercial package of 1 bottle in 1 carton / 36 tablet, film coated in 1 bottle of Lucemyra, a human prescription drug labeled by Uswm, Llc. This tablet, film coated is formulated for oral use and contains lofexidine hydrochloride 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 Uswm, Llc on February 09, 2021.

What are the primary indications for this medication?

Lofexidine is used to decrease withdrawal symptoms caused by stopping opioids. It can be used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How is this Uswm, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78670005036. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
78670-050-36
11-Digit CMS (5-4-2)
78670-0050-36

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