Drugplain

oxybutynin 10 mg/1

oxybutynin · TABLET, FILM COATED, EXTENDED RELEASE · NCS HealthCare of KY, LLC dba Vangard Labs

10 Recalls on Record
Plain English

Oxybutynin is a prescription medication taken by mouth that helps reduce bladder muscle spasms and control symptoms like urgent or frequent urination and incontinence. This extended-release tablet form is designed to release the medication slowly throughout the day.

Key Facts

Brand Name
oxybutynin
Generic Name
oxybutynin
NDC Code (Product)
0615-8220
Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA202332
Marketing Start
08/10/2017

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

Frequently Asked Questions

What is oxybutynin used for?

Oxybutynin is a prescription medication taken by mouth that helps reduce bladder muscle spasms and control symptoms like urgent or frequent urination and incontinence. This extended-release tablet form is designed to release the medication slowly throughout the day.

Is oxybutynin a controlled substance?

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

What is the generic name for oxybutynin?

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

What is the NDC code for oxybutynin 10 mg/1?

The NDC (National Drug Code) for oxybutynin 10 mg/1 is 0615-8220, listed by NCS HealthCare of KY, LLC dba Vangard Labs.

Product NDC

0615-8220

Package NDC

0615-8220-39

Other oxybutynin Dosages

Other Oxybutynin Brands

See all →

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

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