Drugplain

MYCOPHENOLIC ACID 180 mg/1

MYCOPHENOLIC ACID · TABLET, DELAYED RELEASE · Aurobindo Pharma Limited

3 Recalls on Record
Plain English

MYCOPHENOLIC ACID is a tablet, delayed release containing mycophenolic acid at 180 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name
MYCOPHENOLIC ACID
Generic Name
MYCOPHENOLIC ACID
NDC Code (Product)
59651-621
Manufacturer
Aurobindo Pharma Limited
Strength
180 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA218603
Marketing Start
02/27/2024

Recall History

3 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014.

TerminatedVoluntary: Firm initiated
Class II09/03/2024

Ascend Laboratories, LLC

Failed Dissolution Specifications

OngoingVoluntary: Firm initiated
Class II05/20/2015

Mylan Lab Inc

Failed Dissolution Specifications: Low out of specification dissolution results.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use2,147 reports
drug ineffective1,456 reports
diarrhoea1,030 reports
acute kidney injury868 reports
covid-19794 reports
product use in unapproved indication744 reports
pyrexia740 reports
drug interaction717 reports
nausea713 reports
death680 reports

Frequently Asked Questions

What is MYCOPHENOLIC ACID used for?

MYCOPHENOLIC ACID contains MYCOPHENOLIC ACID. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is MYCOPHENOLIC ACID a controlled substance?

MYCOPHENOLIC ACID is not classified as a controlled substance by the DEA.

What is the generic name for MYCOPHENOLIC ACID?

The generic name for MYCOPHENOLIC ACID is MYCOPHENOLIC ACID. There are 8 other brand versions of MYCOPHENOLIC ACID.

What is the NDC code for MYCOPHENOLIC ACID 180 mg/1?

The NDC (National Drug Code) for MYCOPHENOLIC ACID 180 mg/1 is 59651-621, listed by Aurobindo Pharma Limited.