Methadone Hydrochloride Concentrate
NDC Package 0054-0392-68

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

Package Information

Methadone Hydrochloride concentrates is 1.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). This formulation utilizes a concentrate delivery system. Marketed by Hikma Pharmaceuticals Usa, this product is identified by NDC 0054-0392 and is authorized under FDA application ANDA040180.

Identification & Billing

NDC Package Code
0054-0392-68
Package Description
1000 mL in 1 BOTTLE
Product Code
0054-0392
11-Digit Billing Format
00054039268
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1000 ML
RxNorm Crosswalk
  • RxCUI: 991147 - methadone HCl 10 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG/ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG per 1 ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 5 MG per 0.5 ML Oral Solution

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
1.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 2.For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA040180
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-16-2010
Listing Expiration
12-31-2027
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 0054-0392-68 identifies a specific commercial package of 1000 ml in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa. This concentrate is formulated for oral use and contains methadone 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 Hikma Pharmaceuticals Usa on March 16, 2010. The current certification is valid through December 31, 2027.

How is this Hikma Pharmaceuticals Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054039268. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1000 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 (4-4-2)
0054-0392-68
11-Digit CMS (5-4-2)
00054-0392-68

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