Drugplain

Nizatidine 300 mg/1

Nizatidine · CAPSULE · Actavis Pharma, Inc.

3 Recalls on Record
Plain English

Nizatidine is a capsule containing nizatidine at 300 mg/1, taken oral. Manufactured by Actavis Pharma, Inc..

Key Facts

Brand Name
Nizatidine
Generic Name
Nizatidine
NDC Code (Product)
0591-3138
Manufacturer
Actavis Pharma, Inc.
Strength
300 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA075616
Drug Class
Histamine-2 Receptor Antagonist [EPC]
Marketing Start
07/09/2002

Recall History

3 Recalls on Record
Class II04/15/2020

Amneal Pharmaceuticals of New York, LLC

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

TerminatedVoluntary: Firm initiated
Class II01/07/2020

Mylan Pharmaceuticals Inc.

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

TerminatedVoluntary: Firm initiated
Class II01/07/2020

Mylan Pharmaceuticals Inc.

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Nizatidine used for?

Nizatidine contains Nizatidine. It is a capsule taken oral. Consult your doctor for specific uses.

Is Nizatidine a controlled substance?

Nizatidine is not classified as a controlled substance by the DEA.

What is the generic name for Nizatidine?

The generic name for Nizatidine is Nizatidine. There are 1 other brand versions of Nizatidine.

What is the NDC code for Nizatidine 300 mg/1?

The NDC (National Drug Code) for Nizatidine 300 mg/1 is 0591-3138, listed by Actavis Pharma, Inc..

Product NDC

0591-3138

Package NDC

0591-3138-30

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

Data from openFDA · Public domain (CC0 1.0)