Methadone Hydrochloride Solution
NDC Package 0054-3555-63

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

Package Information

Methadone Hydrochloride solution is methadone Hydrochloride Oral Solution is indicated for the:1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use•Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.2)], reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.•Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)]. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-3555 and is authorized under FDA application ANDA087393.

Identification & Billing

NDC Package Code
0054-3555-63
Package Description
500 mL in 1 BOTTLE
Product Code
0054-3555
11-Digit Billing Format
00054355563
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 5 mg/5mL
Pharmacologic Class
Usage Information
Methadone Hydrochloride Oral Solution is indicated for the:1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use•Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.2)], reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.•Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA087393
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-1981
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 0054-3555-63 identifies a specific commercial package of 500 ml in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This solution 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 Inc. on May 22, 1981. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054355563. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 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)
0054-3555-63
11-Digit CMS (5-4-2)
00054-3555-63

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