Methadone Hydrochloride Injection
NDC Package 0641-6266-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Methadone Hydrochloride injection is indicated for the 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. This formulation utilizes a injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6266 and is authorized under FDA application ANDA218609.

Identification & Billing

NDC Package Code
0641-6266-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
0641-6266
11-Digit Billing Format
00641626601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
Methadone Hydrochloride Injection is indicated for the 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 UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, (see WARNINGS) reserve Methadone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic.For use in temporary treatment of opioid dependence in patients unable to take oral medication. Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218609
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1230
Source: PDAC
INJECTION, METHADONE HCL, UP TO 10 MG
HCPCS Dosage 10 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0641-6266-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Methadone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intramuscular; intravenous; subcutaneous use and contains methadone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals Usa Inc. on June 12, 2025. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641626601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0641-6266-01
11-Digit CMS (5-4-2)
00641-6266-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.