Lofexidine Tablet, Coated
NDC Package 14445-146-36

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

Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. This formulation utilizes a tablet, coated delivery system. Marketed by Indoco Remedies Limited, this product is identified by NDC 14445-146 and is authorized under FDA application ANDA218613.

Identification & Billing

NDC Package Code
14445-146-36
Package Description
1 BOTTLE in 1 CARTON / 36 TABLET, COATED in 1 BOTTLE
Product Code
14445-146
11-Digit Billing Format
14445014636
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lofexidine
Non-Proprietary Name
Lofexidine
Substance Name
Lofexidine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOFEXIDINE HYDROCHLORIDE .18 mg/1
Usage Information
Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Regulatory & Marketing

Labeler Name
Indoco Remedies Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218613
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2024
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 (14445-146). Click a package code to view its specific billing and regulatory data.

14445-146-96
1 BOTTLE in 1 CARTON / 96 TABLET, 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 14445-146-36 identifies a specific commercial package of 1 bottle in 1 carton / 36 tablet, coated in 1 bottle of Lofexidine, a human prescription drug labeled by Indoco Remedies Limited. This tablet, 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 Indoco Remedies Limited on August 21, 2024. The current certification is valid through December 31, 2026.

How is this Indoco Remedies Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14445014636. 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)
14445-146-36
11-Digit CMS (5-4-2)
14445-0146-36

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