Drugplain

DEXTROMETHORPHAN HBR 15 MG 15 mg/1

DEXTROMETHORPHAN HBR 15 MG · CAPSULE, LIQUID FILLED · AMZ789 LLC

1 Recall on Record
Plain English

DEXTROMETHORPHAN HBR 15 MG is a capsule, liquid filled containing dextromethorphan hbr 15 mg at 15 mg/1, taken oral. Manufactured by AMZ789 LLC.

Key Facts

Brand Name
DEXTROMETHORPHAN HBR 15 MG
Generic Name
DEXTROMETHORPHAN HBR 15 MG
NDC Code (Product)
73629-005
Manufacturer
AMZ789 LLC
Strength
15 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
05/01/2022

Recall History

1 Recall on Record
Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug abuse109 reports
cardiac arrest21 reports
completed suicide21 reports
respiratory arrest21 reports
death16 reports
toxicity to various agents12 reports
drug hypersensitivity10 reports
overdose6 reports
drug interaction5 reports
intentional drug misuse5 reports

Frequently Asked Questions

What is DEXTROMETHORPHAN HBR 15 MG used for?

DEXTROMETHORPHAN HBR 15 MG contains DEXTROMETHORPHAN HBR 15 MG. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is DEXTROMETHORPHAN HBR 15 MG a controlled substance?

DEXTROMETHORPHAN HBR 15 MG is not classified as a controlled substance by the DEA.

What is the generic name for DEXTROMETHORPHAN HBR 15 MG?

The generic name for DEXTROMETHORPHAN HBR 15 MG is DEXTROMETHORPHAN HBR 15 MG. There are no other listed brand versions of DEXTROMETHORPHAN HBR 15 MG.

What is the NDC code for DEXTROMETHORPHAN HBR 15 MG 15 mg/1?

The NDC (National Drug Code) for DEXTROMETHORPHAN HBR 15 MG 15 mg/1 is 73629-005, listed by AMZ789 LLC.

Product NDC

73629-005

Package NDC

73629-005-10

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)