Drugplain

METHADONE HYDROCHLORIDE 10 mg/1

METHADONE HYDROCHLORIDE · TABLET · SpecGx LLC

4 Recalls on Record
Plain English

Methadone hydrochloride is an opioid medication taken by mouth that is used to treat severe pain and to help people manage opioid addiction. It works by changing how the brain and nervous system respond to pain and can reduce cravings in people with opioid use disorder.

Key Facts

Brand Name
METHADONE HYDROCHLORIDE
Generic Name
METHADONE HYDROCHLORIDE
NDC Code (Product)
0406-5771
Manufacturer
SpecGx LLC
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA040517
Marketing Start
04/27/2004

Recall History

4 Recalls on Record
Class II01/18/2017

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

TerminatedVoluntary: Firm initiated
Class III12/19/2024

West-Ward Columbus Inc

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

OngoingVoluntary: Firm initiated
Class II01/18/2017

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

TerminatedVoluntary: Firm initiated
Class II01/18/2017

VistaPharm, Inc.

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is METHADONE HYDROCHLORIDE used for?

Methadone hydrochloride is an opioid medication taken by mouth that is used to treat severe pain and to help people manage opioid addiction. It works by changing how the brain and nervous system respond to pain and can reduce cravings in people with opioid use disorder.

Is METHADONE HYDROCHLORIDE a controlled substance?

Yes, METHADONE HYDROCHLORIDE is classified as CII under the DEA Controlled Substances Act.

What is the generic name for METHADONE HYDROCHLORIDE?

The generic name for METHADONE HYDROCHLORIDE is METHADONE HYDROCHLORIDE. There are 10 other brand versions of METHADONE HYDROCHLORIDE.

What is the NDC code for METHADONE HYDROCHLORIDE 10 mg/1?

The NDC (National Drug Code) for METHADONE HYDROCHLORIDE 10 mg/1 is 0406-5771, listed by SpecGx LLC.