Drugplain

METHADONE HYDROCHLORIDE 10 mg/5mL

METHADONE HYDROCHLORIDE · SOLUTION · SpecGx LLC

4 Recalls on Record
Plain English

Methadone hydrochloride is an opioid medication used to treat severe pain and to help people manage opioid addiction. This oral solution contains 10 mg of methadone in each 5 mL dose and requires a prescription from your doctor.

Key Facts

Brand Name
METHADONE HYDROCHLORIDE
Generic Name
METHADONE HYDROCHLORIDE
NDC Code (Product)
0406-6221
Manufacturer
SpecGx LLC
Strength
10 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA207537
Marketing Start
06/18/2021

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 used to treat severe pain and to help people manage opioid addiction. This oral solution contains 10 mg of methadone in each 5 mL dose and requires a prescription from your doctor.

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/5mL?

The NDC (National Drug Code) for METHADONE HYDROCHLORIDE 10 mg/5mL is 0406-6221, listed by SpecGx LLC.