NDC Package 71335-0493-4 Methadone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
71335-0493-4
Package Description:
112 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Methadone Hydrochloride
Usage Information:
Methadone Hydrochloride Tablets, USP are 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 UseBecause 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 Hydrochloride Tablets, USP 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 Tablets, USP are 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. (1)Limitations of UseMethadone 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:
71335049304
NDC to RxNorm Crosswalk:
  • RxCUI: 864718 - methadone HCl 5 MG Oral Tablet
  • RxCUI: 864718 - methadone hydrochloride 5 MG Oral Tablet
  • Labeler Name:
    Bryant Ranch Prepack
    Sample Package:
    No
    Start Marketing Date:
    09-15-2015
    Listing Expiration Date:
    12-31-2023
    Exclude Flag:
    I
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    71335-0493-190 TABLET in 1 BOTTLE
    71335-0493-230 TABLET in 1 BOTTLE
    71335-0493-3120 TABLET in 1 BOTTLE
    71335-0493-560 TABLET in 1 BOTTLE
    71335-0493-6180 TABLET in 1 BOTTLE
    71335-0493-728 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-0493-4?

    The NDC Packaged Code 71335-0493-4 is assigned to a package of 112 tablet in 1 bottle of Methadone Hydrochloride, labeled by Bryant Ranch Prepack. The product's dosage form is and is administered via form.

    Is NDC 71335-0493 included in the NDC Directory?

    No, Methadone Hydrochloride with product code 71335-0493 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Bryant Ranch Prepack on September 15, 2015 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71335-0493-4?

    The 11-digit format is 71335049304. 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 5-4-1 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
    5-4-171335-0493-45-4-271335-0493-04