NDC Package 0054-3553-44 Methadone Hydrochloride

Concentrate 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:
0054-3553-44
Package Description:
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone Hydrochloride
Substance Name:
Methadone Hydrochloride
Usage Information:
Methadone Hydrochloride INTENSOLTM (oral concentrate) is indicated for the:•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 UseoBecause 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, reserve methadone 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.oMethadone is not indicated as an as-needed (prn) analgesic. •Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).•Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid AddictionCode of Federal Regulations, Title 42, Sec 8Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment: During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis). During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).
11-Digit NDC Billing Format:
00054355344
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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 Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 5 MG per 0.5 ML Oral Solution
Product Type:
Human Prescription Drug
Labeler Name:
Hikma Pharmaceuticals Usa Inc.
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.
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA089897
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-06-1988
Listing Expiration Date:
12-31-2026
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0054-3553-67946 mL in 1 BOTTLE

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Frequently Asked Questions

What is NDC 0054-3553-44?

The NDC Packaged Code 0054-3553-44 is assigned to a package of 1 bottle in 1 carton / 30 ml in 1 bottle of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is concentrate and is administered via oral form.

Is NDC 0054-3553 included in the NDC Directory?

Yes, Methadone Hydrochloride with product code 0054-3553 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on September 06, 1988 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0054-3553-44?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 0054-3553-44?

The 11-digit format is 00054355344. 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
4-4-20054-3553-445-4-200054-3553-44