Drugplain

METHADONE HYDROCHLORIDE 10 mg/1

METHADONE HYDROCHLORIDE · TABLET · Hikma Pharmaceuticals USA Inc.

4 Recalls on Record
Plain English

Methadone hydrochloride is an opioid medication taken by mouth that is used to treat pain and opioid use disorder. This 10 mg tablet form requires a prescription from a doctor.

Key Facts

Brand Name
METHADONE HYDROCHLORIDE
Generic Name
METHADONE HYDROCHLORIDE
NDC Code (Product)
0054-0710
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA088109
Marketing Start
03/08/1983

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 pain and opioid use disorder. This 10 mg tablet form requires a prescription from a 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/1?

The NDC (National Drug Code) for METHADONE HYDROCHLORIDE 10 mg/1 is 0054-0710, listed by Hikma Pharmaceuticals USA Inc..