Drugplain

OXYBUTYNIN CHLORIDE 5 mg/1

OXYBUTYNIN CHLORIDE · TABLET · Leading Pharma, LLC

10 Recalls on Record
Plain English

OXYBUTYNIN CHLORIDE is a tablet containing oxybutynin chloride at 5 mg/1, taken oral. Manufactured by Leading Pharma, LLC.

Key Facts

Brand Name
OXYBUTYNIN CHLORIDE
Generic Name
OXYBUTYNIN CHLORIDE
NDC Code (Product)
69315-182
Manufacturer
Leading Pharma, LLC
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA212798
Marketing Start
11/01/2019

Recall History

10 Recalls on Record
Class II10/19/2023

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

CompletedVoluntary: Firm initiated
Class II09/21/2023

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II10/19/2023

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

CompletedVoluntary: Firm initiated
Class III02/07/2014

Actavis

Subpotent Drug: Drug potency was compromised during shipment.

TerminatedVoluntary: Firm initiated
Class II10/19/2023

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

CompletedVoluntary: Firm initiated
Class II12/11/2018

KVK-Tech, Inc.

Labeling: Wrong bar code

TerminatedVoluntary: Firm initiated
Class III03/01/2019

AVKARE Inc.

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014.

TerminatedVoluntary: Firm initiated
Class III02/21/2019

Lannett Company Inc.

Failed Dissolution Specifications

TerminatedN/A
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue713 reports
drug ineffective684 reports
nausea586 reports
fall574 reports
headache547 reports
diarrhoea499 reports
pain477 reports
urinary tract infection445 reports
dizziness423 reports
constipation401 reports

Frequently Asked Questions

What is OXYBUTYNIN CHLORIDE used for?

OXYBUTYNIN CHLORIDE contains OXYBUTYNIN CHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.

Is OXYBUTYNIN CHLORIDE a controlled substance?

OXYBUTYNIN CHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for OXYBUTYNIN CHLORIDE?

The generic name for OXYBUTYNIN CHLORIDE is OXYBUTYNIN CHLORIDE. There are 11 other brand versions of OXYBUTYNIN CHLORIDE.

What is the NDC code for OXYBUTYNIN CHLORIDE 5 mg/1?

The NDC (National Drug Code) for OXYBUTYNIN CHLORIDE 5 mg/1 is 69315-182, listed by Leading Pharma, LLC.

Product NDC

69315-182

Package NDC

69315-182-01

Other OXYBUTYNIN CHLORIDE Dosages

Other Oxybutynin 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)