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  5. NDC Package Code: 0054-0392-68 Methadone Hydrochloride

NDC Package 0054-0392-68 Methadone Hydrochloride

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
0054-0392-68
Package Description:
1000 mL in 1 BOTTLE
Product Code:
0054-0392
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone Hydrochloride
Substance Name:
Methadone Hydrochloride
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.
11-Digit NDC Billing Format:
00054039268
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
1000 ML
NDC to 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 Concentrate for Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa
    Dosage Form:
    Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METHADONE HYDROCHLORIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040180
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-16-2010
    Listing Expiration Date:
    12-31-2025
    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 0054-0392-68?

    The NDC Packaged Code 0054-0392-68 is assigned to a package of 1000 ml in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa. The product's dosage form is concentrate and is administered via oral form.

    Is NDC 0054-0392 included in the NDC Directory?

    Yes, Methadone Hydrochloride with product code 0054-0392 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa on March 16, 2010 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0054-0392-68?

    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 1000.

    What is the 11-digit format for NDC 0054-0392-68?

    The 11-digit format is 00054039268. 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
    4-4-20054-0392-685-4-200054-0392-68