Methadone Hydrochloride
NDC Package 63629-1027-1
Package Information
Methadone Hydrochloride is tablets, USP are 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 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 [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 immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone hydrochloride tablets are 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 8: Methadone 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. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-1027 and is authorized under FDA application ANDA090635.
Identification & Billing
- RxCUI: 864706 - methadone HCl 10 MG Oral Tablet
- RxCUI: 864706 - methadone hydrochloride 10 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63629 - Bryant Ranch Prepack
- 63629-1027 - Methadone Hydrochloride
- 63629-1027-1 - 100 TABLET in 1 BOTTLE
- 63629-1027 - Methadone Hydrochloride
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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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 63629-1027-1 identifies a specific commercial package of 100 tablet in 1 bottle of Methadone Hydrochloride, labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bryant Ranch Prepack on January 16, 2012. The current certification is valid through June 18, 2026.
How is this Bryant Ranch Prepack product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629102701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
