Drugplain

CEVIMELINE HYDROCHLORIDE 30 mg/1

CEVIMELINE HYDROCHLORIDE · CAPSULE · PD-Rx Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Cevimeline hydrochloride is a prescription oral medication taken as a capsule to treat dry mouth (xerostomia), particularly in patients with Sjögren's syndrome. It works by stimulating salivary gland function to increase saliva production.

Key Facts

Brand Name
CEVIMELINE HYDROCHLORIDE
Generic Name
CEVIMELINE HYDROCHLORIDE
NDC Code (Product)
72789-457
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Strength
30 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA216682
Marketing Start
04/06/2023

Recall History

1 Recall on Record
Class II08/17/2015

Apotex Inc.

Failed Stability Specifications: product may not meet specification limit for assay test.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is CEVIMELINE HYDROCHLORIDE used for?

Cevimeline hydrochloride is a prescription oral medication taken as a capsule to treat dry mouth (xerostomia), particularly in patients with Sjögren's syndrome. It works by stimulating salivary gland function to increase saliva production.

Is CEVIMELINE HYDROCHLORIDE a controlled substance?

CEVIMELINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for CEVIMELINE HYDROCHLORIDE?

The generic name for CEVIMELINE HYDROCHLORIDE is CEVIMELINE HYDROCHLORIDE. There are 11 other brand versions of CEVIMELINE HYDROCHLORIDE.

What is the NDC code for CEVIMELINE HYDROCHLORIDE 30 mg/1?

The NDC (National Drug Code) for CEVIMELINE HYDROCHLORIDE 30 mg/1 is 72789-457, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

72789-457

Package NDC

72789-457-01

Other CEVIMELINE HYDROCHLORIDE Dosages

Other Cevimeline Brands

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

Data from openFDA · Public domain (CC0 1.0)