NDC Package 0054-3556-63 Methadone Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0054-3556-63
Package Description:
500 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone Hydrochloride
Substance Name:
Methadone Hydrochloride
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)].
11-Digit NDC Billing Format:
00054355663
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
500 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 864761 - methadone HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 864761 - methadone hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 864761 - methadone HCl 5 MG per 5 ML Oral Solution
  • RxCUI: 864769 - methadone HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 864769 - methadone hydrochloride 2 MG/ML Oral Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA087997
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-30-1982
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0054-3556-63?

    The NDC Packaged Code 0054-3556-63 is assigned to a package of 500 ml in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0054-3556 included in the NDC Directory?

    Yes, Methadone Hydrochloride with product code 0054-3556 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on August 30, 1982 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0054-3556-63?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 0054-3556-63?

    The 11-digit format is 00054355663. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20054-3556-635-4-200054-3556-63