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  5. NDC Package Code: 0904-7417-61 Methadone Hydrochloride

NDC Package 0904-7417-61 Methadone Hydrochloride

Tablet 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:
0904-7417-61
Package Description:
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code:
0904-7417
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone Hydrochloride
Substance Name:
Methadone Hydrochloride
Usage Information:
Methadone Hydrochloride Tablets are indicated for the:1.Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use2.Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve Methadone Hydrochloride Tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.3.Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic.4.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).5.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:
00904741761
NDC to RxNorm Crosswalk:
  • RxCUI: 864706 - methadone HCl 10 MG Oral Tablet
  • RxCUI: 864706 - methadone hydrochloride 10 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Major Pharmaceuticals
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METHADONE HYDROCHLORIDE 10 mg/1
    • 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:
    ANDA088109
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-03-2024
    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 0904-7417-61?

    The NDC Packaged Code 0904-7417-61 is assigned to a package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack of Methadone Hydrochloride, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0904-7417 included in the NDC Directory?

    Yes, Methadone Hydrochloride with product code 0904-7417 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on January 03, 2024 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 11-digit format for NDC 0904-7417-61?

    The 11-digit format is 00904741761. 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
    4-4-20904-7417-615-4-200904-7417-61